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Challenges in Developing and Testing HIV/AIDS Vaccines in Africa

Posted on: Monday, 3 October 2005, 12:01 CDT

By Okeagu, Jonas E; Ademiluyi, Adegoke O; Okeagu, Joseph C; Okeagu, Chinyere I; Onuoha, Chinwe N

INTRODUCTION

Five million people became infected with HIV worldwide and three million died in 2003 alone-the highest ever.1 Two thirds of all people with HIV/AIDS are in Africa. Sub-Saharan Africa is the region of the world that is most affected by HIV/AIDS. An estimated 26.6 million people are living with HIV/AIDS, and approximately 3.2 million new infections occurred in sub-Saharan Africa in 2003. In just the past year, the epidemic has claimed the lives of an estimated 2.3 million Africans. Ten million young people and almost three million children under 15 are living with HIV/AIDS. An estimated eleven million children have been orphaned by AIDS in subSaharan Africa.2

Although there have been more than 45 million cumulative HIV infections in Africa, there have been only two small phase 1 preventive HIV vaccine trials in the continent most severely affected by the pandemic.3 The first HIV vaccine trial in Africa of a product based on HIV strains from that continent began in Nairobi, Kenya in 2001. A collaborative group including Oxford University, UK, the University of Nairobi, Kenya, the Kenyan AIDS Vaccine Initiative (KAVI), and the International AIDS Vaccine Initiative (IAVI) developed DNA Vaccine and modified Vacina Ankara Vaccines on the basis of the gag gene of HIV-I subtype A and multiple cytotoxic Tlymphocyte epitopes, including some identified in studies of exposed uninfected Kenyan female sex workers.4 The second vaccine initiative was in South Africa, using Clade C, the most common subtype in the world.

Currently, nine approved vaccines are being tested world-wide, including six in Africa: one in Botswana, two in Kenya, two in South Africa and one in Uganda.5

Most HIV vaccine development and assessment has taken place in developed western countries. Early efforts to develop an HIV vaccine were based on the HIV-I subtype B strains prevalent in western nations, and most human clinical trials were done in the United States and Europe. Globally, there have been more than 80 Phase I and Phase II trials and only one product-a bivalent recombinant gp120 vaccine (AIDSVAX, VAXGEN Brisbane, CA, USA)-has reached large scale Phase III efficacy testing in North America, the Netherlands and Thailand.6

Studies of multiply exposed but uninfected individuals and long- term nonprogressors provide evidence that cellular responses can provide some protection against HIV/AIDS. Almost all humans develop some form of immune response to HIV infection. Particularly encouraging have been studies of several vaccine concepts tested against simian immunodeficiency virus (SIV), a virus similar to HIV that infects certain species of monkeys.7

A vaccine for Africa would be the best long-term preventive measure against the HIV/AIDS pandemic in the continent. Historically, vaccines have provided a safe, cost effective, and efficient means of preventing illness, disability and death from infectious diseases. Because there are many HIV-I subtypes, circulating recombinant forms, and intersubtype recombinant strains in the continent, and since the distribution of these subtypes will probably change overtime,8 an ideal HIV vaccine for Africa will be one that can protect against all genetically HIV-I strains (polyvalent HIV-I vaccine).

A vaccine is a drug that mimics a dangerous organism or pathogen, and creates immune system memory concerning that specific pathogen.9 A vaccine is antigenically similar to a pathogen or to its toxic by- products but has been treated so that it can be administered to people with little danger of disease. The vaccine sensitizes the immune system to the corresponding pathogen, inducing immunity without the danger of infectious disease developing during the lag period. In immunized people, natural exposure to the corresponding virulent pathogen triggers a protective anamnestic response that eradicates the pathogen or neutralizes toxins before symptoms of disease develop. An effective vaccine retains the corresponding pathogen's antigens but none of the pathogen's ability to damage the host. This is accomplished in a number of ways including the use of killed and attenuated organisms, purified antigen-fractions, toxoid, synthetic peptides and anti-idiotype antibodies.10

Vaccines are disease specific: A vaccine against polio protects only against polio and a vaccine against HIV infection protects only against HIV. In the case of a vaccine against viruses, this can either be an "inactivated" virus or an attenuated or mild form of a "live" virus.11

Inactivated vaccines are viruses that have lost their infectivity through damage to their nucleic acid by various agents such as formaldehyde or U. V. irradiation. These inactivating agents and treatments must be carefully selected and controlled so that they will not affect the antigenic specificity of the protein surface of the respective virus.

Live vaccines are virus strains that through passage of a typical host animal or cultured cells, have been made to mutate and have become "mild" or of low virulence, for the species to be vaccinated.

Both modes of vaccination have surely saved millions of lives and turned serious and often epidemic diseases into minor discomforts. Each type of vaccine can represent problems and dangers. Live vaccines may be too mild to elicit an immunologie response, or they retain sufficient infectivity to cause the disease. They may contain other contaminating unattenuated viruses.

Inactivated vaccines have the danger that a minuscule proportion of virus particles may 'survive' the chemical treatment and produce the disease that the vaccine is supposed to prevent.

HISTORICAL PERSPECTIVES

The ancient Chinese knew that a person scarred by smallpox would not again get the disease. They took dried scabs from lesions of people who were recovering from the disease and ground them into a powder that they sniffed. As a result of inhaling weakened organisms, they acquired a mild case of smallpox but were protected against subsequent infection.12

Smallpox was unknown in Europe until the Crusaders carried it back from the Near East in the 12th century. The Spaniards carried the virus to the West Indies in 1507, and Cortez's army introduced it into Mexico in 1520. Slave traders introduced smallpox into Central Africa in the 16th and 17th centuries. Immigrants from India brought it to South Africa in 1713. The disease reached Australia in 1789. By the seventeenth century it was widespread, and in 1717, Lady Montagu, wife of the British ambassador to Turkey, introduced a kind of immunization to England. A thread was soaked in fluid from a smallpox vesicle (blister) and drawn through a small incision in the arm. The technique called variolation was used at first by only a few prominent people, but eventually it became widespread.

Variolation can be a useful form of protection, but the virulence of the pathogen is uncertain, and on occasion the procedure may backfire and kill the recipient. One person who received this treatment at the age of eight was Edward Jenner. Later in life as a physician, Jenner was intrigued by a dairymaid's assertion that she had already had cowpox, (cowpox is a mild disease that causes lesion on cow's udders; a dairymaid's hands often became infected during milking). Motivated by this childhood memory of variolation, Jenner inoculated his own son with fluid from a cowpox blister. He later similarly inoculated an 8-year old boy, (James Phipps)13 and subsequently courageously inoculated the same child with smallpox. The child remained healthy.

A similar circumstance exists in part of Africa, where HIV-I and HIV-2 are both circulating. Phyllis Kanki,14 an epidemiologist at the Harvard University School of Public Health, studied female prostitutes in Senegal for 9 years. She found that women who had HIV- 2 infection were less likely to acquire HIV-1 infection. She and her colleagues examined whether the HIV-2 infected women adopted safer sex practices once they were infected and found that they did not. Kanki does not believe that attenuated HIV-2 would be a safe vaccine, but the HIV-2 proteins that generate an immune response could provide a safe and effective HIV-I vaccine.

Jenner's technique spread through Europe, but it was a hundred years later before it was applied to other diseases by Louis Pasteur.15 By accident, Pasteur returned from vacation and injected some chickens with cholera that had been fatal before his vacation. To his surprise, the chickens recovered. Aging had weakened this cholera bacteria, which could then be used to protect against diseases; this is called attenuated strain.

Pasteur extended his findings to other diseases. He applied this principle of immunization to the prevention of anthrax, and again it worked. He called the avirulent cultures (lacking pathogenicity) vaccines (from the Latin Vacca "Cow") and immunization with such cultures, vaccination in honor of Edward Jenner,16 for his pioneering work in Immundogy. By using these terms, Pasteur recognized the earlier work of Edward Jenner (17491823), who had successfully vaccinated a boy against smallpox in 1708. Although Pasteur proved that vaccination worked, he di\d not understand the mechanisms involved. He developed his vaccine empirically, that is by trial and error. Even today some scientists believe that the best way to develop HIV/AIDS vaccine is to put resources into working out the mechanism of protection, while others believe in the empirical approach.

OBSTACLES TO HIV/AIDS VACCINE DEVELOPMENT POSED BY HUMAN IMMUNODEFICIENCY VIRUS

Although more than 28 million Africans are HIV positive, less than 2% of world research funding goes towards fighting the viral subtypes most common in Africa. Of more than 30 HIV vaccine trials conducted throughout the world since 1987, only two were carried out in Africa.17 The development of HIV/AIDS vaccines in Africa has been prevented by a number of obstacles inherent in human immunodeficiency virus. One is lack of suitable animal host that develops recognizable AIDS. Much current work makes use of monkeys and the simian immunodeficiency virus (SIV), which has many similarities to HIV.

The rapid mutation rate of HI V makes it difficult to develop a vaccine that is effective against all forms of the virus.18 HIV continues to mutate the sites where destructive antibodies might attach, meaning that a vaccine effective against one subtype may have no activity against the others and that new strains can develop that might be able to escape the effects of a vaccine. Like other RNA virus, HIV mutates rapidly, producing antigenically heterogenous viruses, within a single person.19 There are genetically distinct subtypes or clades of HIV circulating, with the predominant subtype varying by regions.20 The remarkable genetic diversity of HIV-1 strains in Africa is a major hurdle to the development of a broadly protective vaccine.21 Although all known HIV-1 subtypes and an array of intersubtype recombinant viruses, often in complex mosaic forms, are found throughout the continent, the major HIV-1 subtypes accounting for most infections in Africa are Subtype C in southern Africa, subtypes A and D in eastern Africa, and circulating recombinant form 02-AG (CRF02,AG) in West-Central Africa. It is difficult to create subtype specific vaccines.

HIV may be transmitted as a cell-free virus and by HIV infected cells. Therefore, neutralizing antibodies alone is unlikely to be sufficient to prevent infection. Moreover, during much of the HIV life cycle, potential points of attack are covered in a protective armor of sugar compounds and as a result are not vulnerable to the immune system.22

Classic vaccines mimic natural immunity against reinfection generally seen in individuals who have recovered from infection; there are no recovered AIDS patients. Most vaccines protect against disease, not against infection; HIV infection may remain latent for long periods before causing AIDS. Most effective vaccines are whole- killed or live-attenuated organism; killed HIV does not retain antigenicity and the use of a live retrovirus raises safety issues. Most vaccines protect against infections that are infrequently encountered; HIV may be encountered daily by individuals at high risk.23

Another obstacle is the variety of routes by which HIV can be transmitted. An effective vaccine would have to protect against transmission by different mucosal routes, which has proved to be an elusive goal in six tests that have been made in monkeys, and against both virus containing cells and free viruses.24 Infections localized on the mucous membranes are not affected by circulating antibodies and are generally controlled by secretary IgA. Unfortunately immunologie recall is less efficient with these secretary immunoglobins than with circulating antibodies. Diseases restricted to the urogenital mucosa stimulate poor natural immunity during infection and are less likely to be controlled by vaccines.24 HIV suppresses immunologie response during natural infection. Unfortunately, vaccines prepared against AIDS may similarly depress immunity rather than enhance it.25

One of the challenges to scientists who strive to develop an HIV/ AIDS vaccine is getting an understanding of which immune responses in a person's body would protect it from the disease.26 There is strong evidence for a cellular response. Vaccines are most successful against diseases controlled by humoral immunity, largely the work of B-cells which neutralize infections against agents in the liquid (non-cellular) part of the blood. Few vaccines are available against diseases controlled primarily by cell-mediated immunity (CMI) organized primarily by T-cells, which kill the body's own cells when they become infected with a pathogen. B-cells produce antibodies - proteins that stick to free-floating invaders in the blood stream to dissolve them and mark them for destruction.27

SOCIAL AND ECONOMIC FACTORS

In African countries, poverty, denial, lack of leadership, commitment and collaboration28 have crippled the response to HIV/ AIDS vaccine initiatives. Poverty increases the risk and reduces the capacity to respond. For many Africans, HIV/AIDS is simply one more threat to survival, and not the worst immediately visible as compared to war, drought, violent crime, impoverishment or other endemic killer diseases such as malaria.29 Both the internal vulnerabilities of African societies and their marginalization within the current world order are reflected in the catastrophic course of the HIV/AIDS pandemic on the continent and the lack of progress in HIV/AIDS vaccine initiatives. For more than two decades the pandemic has raced ahead of the global response especially in subSaharan Africa. While HIV/AIDS affects people of all races and income levels, both men and women, the crunch of the burden is on black, poor and female, and most of those dying of HIV/AIDS are from subSaharan Africa. As the president of Botswana once remarked, the survival of entire nations is at risk. AIDS has already become the worst plague in human history.

HIV/AIDS vaccines for Africa have proven elusive not just due to tough scientific challenges but also due to economics and politics: money and interests have been sorely lacking, as the greatest need for a vaccine is in African countries least able to pay.30 Therefore, the most important barrier to demand for an AIDS vaccine in Africa is likely to be the affordability. Most researchers have assumed that an AIDS vaccine would be fully subsidized by African governments or international donors. However, most recently developed vaccines have been both expensive and only partially subsidized. It is likely that an AIDS vaccine will require at least some out of pocket payment by consumers in African countries.31 At least they will have to pay for the cost of transport to sites where the vaccine is available.

Vaccines have never been as commercially successful as other medical treatments, and so entering the field of HIV vaccine development is a risk for companies. The largest market for a vaccine will be in African countries with a high prevalence of HIV/ AIDS. But these countries are also the poorest and will not have the resources to buy and distribute the vaccine.32

In addition, research infrastructures are often inadequate in Africa. The African AIDS Vaccine Program (AAVP) hopes to raise U.S. $233 million part of which will be used to build up regional facilities and strengthen local expertise. Considering that the average cost of developing a new prescription drug in the United States is $800 million, $233 million to save many lives seems a very inexpensive tag.33

A successful HIV/AIDS vaccine will necessarily utilize technologies covered by patents. Traditionally, vaccines and drugs are made and sold exclusively in industrialized countries, until decades later when research costs have been recouped and the price drops low enough for other areas.34 Intellectual property protections, important incentives for innovation may run into conflict with efforts to eradicate HIV/AIDS in Africa.

SECURING HUMAN SUBJECTS FOR HIV/AIDS VACCINE TRIALS

Because of the fear and stigmatization surrounding HIV infection, those conducting HIV vaccine trials in Africa must include safeguards for the volunteers against discrimination or harm emanating from a mistaken belief that they have been infected with HIV.35

In much medical research, the potential risk to the participant is limited to the direct effects of the study, such as drug side effects. But HIV vaccine researchers must anticipate-and try as much as possible to head off-an array of social externalities that could befall volunteers. Many of those most at risk for HIV infection-sex workers, men who have sex with men (MSM), and injection drug users (IDU)-face social or legal threats because of the behaviors that put them at risk. Mere participation in the trial might stigmatize volunteers as being members of such risk groups. In some cases, the legal and social stigma may be so severe as to make certain types of research impossible. Even in less oppressive environments, researchers must take into account the vulnerability of the populations that they study and make every effort to minimize harm.36

Vaccination may induce antibodies that will be detected in diagnostic enzyme-linked immunosorbent assays.37 In general, these have transient effects, fading within 1-2 years. Nevertheless, sensitive HIV tests may be employed with or without a volunteer's knowledge to screen for HIV infection. Vaccines derived from the envelope of human immunodeficiency virus will produce anomalous Western blot patterns that may not be recognized as vaccine- induced, particularly if there is a nonspecific band in the region of P24. It is more difficult to distinguish more complex vaccines inducing gag or pol or regulatory proteins from authentic infection.

Voluntary disclosures of vaccine trial participation can lead to discrimination if friends, family or employers misunderstand the purpose of the trial, and believe the volunteer has the HIV infection. A po\sitive test may result in employment, housing, or other discriminations, which are not prohibited by law in many African countries. It is important to find ways to prevent discrimination and avoid conferring a stigma on people who enter trials if the trials are to attract a sufficient number of volunteers to produce meaningful and useful results.

Africans face special ethical concerns in research studies run by foreign researchers.38 In Nigeria, Islamic leaders in three northern states blocked polio inoculations, calling them part of a U.S. plot to spread AIDS or infertility among muslims. Muslims in Nigeria's arid north have been wary of vaccine initiatives since 1996 when families accused Pfizer, Inc. of using an experimental meningitis drug on patients without fully informing them of the risks.39

In the wake of grotesque experiments performed by Nazi scientists on concentration camp inmates during World War II, the 1947 Nuremberg Code established "Voluntary Consent" of human subjects as a bedrock principle of medical research.40 Over the years (particularly through the example of the infamous Tuskegee Syphilis experiment in which African-American male participants were not told they were being denied treatment that could cure their illness), it has become clear that consent is only meaningful if it is informed. Informed consent means that each potential subject must be adequately informed of the aims, methods, source of funding, any possible conflicts of interest, institutional affiliations of the researchers, the anticipated benefits and potential risks of the study and the discomfort it may entail. Researchers think that it is difficult to give as balanced a view as possible because sometimes the press complicates the process. Researchers cannot control the press, but they do have an obligation to make sure journalists understand all the risks and uncertainties involved in research. Part of the informed consent may entail addressing the misunderstandings created in volunteers' minds by exaggerated or oversimplified press accounts.

To demonstrate the benefits of any vaccine, efficacy trials will need to recruit participants at high risks for HIV infection, including poor, illiterate villagers in rural parts of Africa. This requirement brings up issues that rarely arise in U.S. or European AIDS treatment. It is very difficult to explain the intricacies of research to people who have no experience with the process. In such circumstances, the inherent power imbalance between educated, relatively wealthy researchers and their poorer, socioeconomically disadvantaged potential volunteers becomes a barrier and-combined with cultural differences-can undermine the informed consent process.41

Researchers must therefore deal with different cultural norms in consent and decision-making. Researchers have a tremendous responsibility. They must not take advantage of poverty, lack of education, or social vulnerability of potential research participants.

Western cultures tend to emphasize the individual, but in traditional African societies, the norm is group decision making, or for a tribal council or chief to make decisions for the group.42 In these contexts, researchers obtaining only the consent of the individual participant are in violation of some fundamental norms of the community, and the consent of other members of the community (marital partners, family, chief and so on) needs to be obtained for the research to be both ethical and culturally informed. In some patriarchal African societies, women may not be able to give consent easily without the consent of their husbands. Therefore, the principle of first person consent based on respect for individuals should be universally applied in medical research, even if this should be supplemented with consent from other people from the community.

Every volunteer in a preventive vaccine trial will need to receive counseling about how to avoid HIV infection. There is wide spread agreement that participants should receive state of the art prevention including counseling, access to condoms, and to the degree legally possible, clean needles. Nevertheless, a vaccine's ability to prevent infection will be measured by comparing seroconversion rates among those receiving the vaccine with those taking a placebo (an inactive substance), creating a dilemma: the more effectively counseling discourages risky behavior, the harder it will be to measure a vaccine's effect. This creates an inherent conflict of interest that can be avoided by having the prevention activities handled by people other than the research team who have no vested interest in the results.43

The most hotly debated question in HIV vaccine research in Africa has been whether study sponsors have an obligation to provide antiretroviral treatment for volunteers who become infected during the trial. Again, the gap between developed countries and African nations looms large. In most states in the United States, a variety of programs makes access to anti-HIV treatment nearly universal, but this is not the case in Africa. The Declaration of Helsinki44 stated flatly that in any medical study, every patient-including those of a control group, if any-should be assured of the best proven diagnostic and therapeutic method. If highly active antiretroviral therapy (HAART) is the standard of care for HIV/AIDS, it must be available to any vaccinees who become infected, however poor, and wherever they live. Some people argue that since trials will need to look for any effect of vaccine-induced immunity or disease progression in those who become infected providing HAART would make it impossible to gather accurate data. Others argue that it would be immoral to delay vaccine trials that might save millions of Africans while negotiating access to treatment (and the associated viral load testing) in places with no infrastructure for such medical care.

The Joint United Nations Program45 on HIV/AIDS held meetings in Switzerland, Brazil, Thailand and Uganda in an effort to forge an international consensus. What emerged were such sharp disagreements that the UN eventually compromised, suggesting in its official guidance document that the issue of treatment access should be decided locally rather than through an international standard.

Eventually an HIV vaccine will likely demonstrate at least some protection against infection with the virus, but almost no one expects the first successful candidate to be anywhere near 100% effective. This presents the dilemma of how to balance the benefits a partially effective vaccine will offer some people against the harm caused by giving others a false sense of security.46

Even a completely effective vaccine provides no protection to communities that never received it. In a recent policy paper47, the International AIDS Vaccine Initiative (IAVI) noted that vaccines have typically reached developing countries an average of 20 years after being licensed in developed nations. Waiting to address access issues until after AIDS vaccines are licensed will sentence millions of African HIV/AIDS victims to preventable illness and death. When it funds vaccine trials, IAVI requires the product's developers to agree in writing to affordable pricing in developing countries and to give IAVI the right to seek other manufacturers if affordability criteria are not met.

CONCLUSION

Africa clearly needs vaccines to fight the growing catastrophe and menace of the HIV/AIDS pandemic, but the vast majority of vaccine research and testing has occurred in other continents. The barriers to the development of HIV/AIDS vaccines in Africa include the vast and rapidly increasing genetic diversity of HIV; lack of understanding about the biology of the virus-host interaction, and the social and technical complexity of required clinical trials.48HIV mutates very rapidly, producing a mixture of antigenically distinct viruses even within one infected individual. HIV is transmitted both as cell-free virions and by HIV-infected cells, and different types of responses may be required to counteract this.49 In addition, there is a question of usage, whether the vaccine be employed to prevent infection of healthy individuals or alternatively to slow progression of the disease in those already infected with HIV. In experimental primate models, application of a vaccine against HIV has been protective for only a short period and only when the vaccine strain is identical to the infecting virus. Likewise, it is clear that natural infection with HIV does not confer significant protective immunity.

Traditional approaches to vaccine development have involved immunization with either inactivated virus, or recombinant HIV proteins using an adjuvant. Unfortunately, the immunity is brief and does not stimulate the production of cytotoxic T-cells. An alternative approach, the use of a modified live virus in the vaccine, has a major drawback: the mutation rate of the virus is such that it could easily become virulent-an unacceptable result. Because of these problems, considerable attention has been paid to newer approaches to the development of an AIDS vaccine. Synthetic HIV protein epitopes have not stimulated a significant protective response in animals, nor have combined approaches using live recombinant products together with recombinant vaccines been any more successful. Some potential HIV vaccines are currently being tested for safety in humans. These include vaccines containing recombinant envelope glycoproteins, synthetic peptides, and recombinant pox viruses. Unfortunately, none has been highly protective in animal models.50

The barriers to HIV/AIDS vaccine trials in Africa include informed consent, social harm, counseling, treatment, approval and access,51 affordability, effectiveness, safety and perceptions of risk.52 Informed consent in Africa involves not just an individual but also the entire family and commu\nity. The involvement of family and community is the essence of the extended family system practiced in Africa. Social harm concerns the issue of stigmatization and discrimination of volunteers, jeopardizing their employment, housing and immigration. Treatment and access border on affordability and economic realities.

There is a need for highest ethical standards in HIV/AIDS vaccine trials in Africa. Poor Africans should not be coerced into taking part in HIV/AIDS vaccine trials by families or communities who give a "block consent." African women are particularly vulnerable, since in many African societies, women do not have the right to make an informed consent. Based on lessons learned from the Tuskegee Syphilis experiment53 it is mandatory that Africans be informed of any risks involved in trials, the process and research findings by companies.

The first trial of HIV-1 vaccine (AL VAC-VCP 205), based on a clade not common in Uganda,54 encountered social, political, legal and ethical barriers to completing the trial. This manifested itself in widespread public and media fear about the risk of taking part in the trial, including the risk of becoming infected and being treated as laboratory guinea pigs.55 Political commitment and proper infrastructures, including trained, indigenous personnel are necessary for successful vaccine trials in Africa. In light of the many myths surrounding HIV/AIDS vaccine, researchers must build good working relationships with the media, scientists and the community.56

There remains significant concerns about the effectiveness and potential safety of an HIV/AIDS vaccine. It is nearly certain that any HIV/AIDS vaccine would be less than 100 percent effective, owing to the intrinsic nature of human immunodeficiency virus (complex structure, existence of clades and antigenic drift). Concern about safety is prevalent in African countries where HIV/AIDS tests can be used by employers and government officials to discriminate against those who test HIV/AIDS positive. Vaccines which produce an HIV/ AIDS positive test result are likely to be viewed with tremendous skepticism, even if the population is informed that the vaccine is perfectly safe. Finally, a population's acceptance of an HIV/AIDS vaccine is likely to be limited by their own perceptions of risk.57

The secrets to successful HIV/AIDS vaccine development and trials in Africa include highest level of political and institutional support; a clear national plan to guide HIV vaccine development and assessment; a clearly delineated process for scientific and ethical review of proposals and study protocols; adequate protection of human research participants ; well established HIV surveillance and epidemiology research; community education, sensitization and involvement; informed and engaged media; supportive environment for prevention and intervention research; openness to institutional and international collaborations; development of capacity in research, clinical trials, data management and laboratory facilities; and adequate resources, infrastructures and national commitment.58

The authors' policy prescriptions include a need for the highest level of collaboration among African countries in developing and testing HIV/AIDS vaccines using a multisectorial approach. The United States was founded under the principle that in unity lies strength. A Nigerian adage popular in the Igboland states that when people urinate together at the same spot, the urine foams (Agbako aka nyo mmamiri ya agba ufufu). The idea may sound absurd in an era of HIV/AIDS pandemic but underscores the importance of collaboration (united labor). Collaboration is the essence of democracy (a government of the people; by the people, and for the people). If European countries could unite despite their differences, African countries should wake up, accept the challenges posed by HIV/AIDS pandemic and stop funneling national wealth into Swiss and other foreign banks. They need to invest the money to build research infrastructures for developing HIV/AIDS vaccines. African countries have the capability to develop HIV/AIDS vaccines despite the constant loss of manpower through brain-drain to the countries in the west.

NOTES

1. News: Global AIDS Epidemic Shows No Sign of Abating. UNIFEM Gender and HIV/AIDS Web Portal, http://www.genderandaids.org/ modules.php?name=News&File=article&sid=271, January 19, 2004.

2. HIV and AIDS Statistics in Africa, http://www.avert.org/ subadults.htm, January 19, 2004.

3. P.J. Weidle, T.D. Mastro, A.D. Grant, J. Nkengasong and D. Macharia, (2002). HIV/AIDS Treatment and Vaccine for Africa. Lancet. 359: pp. 2269-67, www.theconcept.com.

4. E.G. Wee, S. Patel, A.J. McMichael, T.A. Hanke. DNA-Based Candidate Human Immunodeficiency Virus Vaccine for Kenya Induces Multispecific T-cell Responses in Rhesus Macques, J. Gen. Virol., 83,2000: pp. 75-80.

5. Global: Highest Ethical Standard Needed in HIV/AIDS Vaccine Trials; http://www.irinnews.org/aidsreport.asp?ReportID=2539 &SelectRegion=Global&Select, February 11, 2004.

6. M. Weidle, T.D. Mastro, A.D. Grant, J. Nkenyasong, and D. Macharia. HIV/AIDS Treatment and HIV Vaccines for Africa. Lancet, 2000, 559: 2261-67, www.thelancet.com.

7. Challenges in Designing HIV Vaccines. National Institute of Allergy and Infectious Diseases. National Institute of Health, US Department of Health and Human Services, http://www.niaid.nihgov/ factsheet/chall vaccoine.htm, January 8, 2004.

8. Jaqui Wise. "An Initiative Aims to Develop a Vaccine Against the HIV Type Most Prevalent in Africa," The Scientist: Africa AIDS Program Launched, http://www.biomedcentral.com/news/20020612/04, January 5, 2004.

9. AIDS Vaccine: Flickers of Progress, But a Long Way to Go; Providing HIV/AIDS Care in a Changing Environment. HRSA Care Actions, http://www.hab.hrsa.gov/publications/March 2002.htm, January 14, 2004.

10. Larry McKane and Judy Kandel. Microbiology, Essential and Applications: Active and Passive Immunity. (New York: McGraw-Hill Publishers, 1996), p. 457.

11. HeinzFraekel-Conrat, Paul C. Kimball and Jay A. Levy. Virology: Viral Vaccine. (New Jersey: Prentice Hall Publishers, 1998), p. 489.

12. Jacquelyn G. Black. Microbiology, Principles and Applications: Immunology. (New Jersey: Prentice Hall Publishers, 1996), p. 13.

13. Jerome, J. Perry and James T. Staley. Microbiology, Dynamics and Diversity: Medical Microbiology and Immunology. (New York: Saunders College Publishing, Harcourt Brace College Publishers, 1997), p. 35.

14. G.J. Tortora, B.R. Funke, and C.E. case. Microbiology, An Introduction: New Weapons Against AIDS. (New York: Addison Wesley Longman Publishes, 1997), p. 448.

15. Bill Snow. Vaccine Basics: A History of Vaccines and What they do. International AIDS Vaccine Initiative, http://www.iavi.org/ science/snowbasics.htm, January 14, 2004.

16. M.J. Pelcar, E.G. Chen, and N.R. Krieg. Microbiology, Concepts and Applications: Immunization. (New York: McGraw-Hill Publishers, 1993), p. 13.

17. Jacqui Wise. An Initiative Aims to Develop a Vaccine Against the HIV Type Most Prevalent in Africa; the Scientist: Africa AIDS Program Launched, http://www.biomedcentral.com/news/ 20020612/04, January 5, 2004.

18. G.J. Tortora, B.R. Funke, and C.E. Case. Microbiology, An Introduction: HIV Vaccines. (New York: Addison Wesley Longman Publishers, 1994), p. 525.

19. HIV Vaccination; General Practice Notebook, http:// www.gpnotebook.com/cache/1341784029.htm, January 9, 2004.

20. AIDS Vaccine: The Unfinished and Underfinished Agenda; International AIDS Vaccine Initiative, http://www.iavi.org/science/ challenges.htm., February 26,2004.

21. P.J. Weidle, T.D. Mastro, A.D. Grant, J. Nkeagasong, and D. Macharia. HIV/AIDS Treatment and HIV Vaccines for Africa. The Lancet, 2003, 359: 2261-2267, www.thelancet.com.

22. AIDS Vaccine: Flickers of Progress, but a long way to Go; Providing HIV/AIDS Care in Changing Environment, HRSA Care Action, 2002; http://www.publications/Marcn2002.htm, January 14, 2004.

23. R.A. Goldsby, T.J. Kindt, and B.A. Osborne. Immunology: Vaccines to prevent AIDS. (New York: W.H. Freeman Publishers, 2002), p. 491.

24. G.J. Tortora, B.R. Funke, and E.E. Case. Microbiology: An Introduction: HIV Vaccine. (New York: Addison Wesley Longman Publishers, 1991), p. 525.

25. Bruce W. Polsky and Nathan Clumeck. HIV/AIDS: Epidemiology of HIV Infection. (London: Harcourt Publishers, 1994), Chapter 4.

26. David Pieribone. On the Trail of a Vaccine: An Interview for David M. Gold. The Body: An AIDS/HIV Information Resource, A Monthly Publication for People with HIV/AIDS, 2002, http://www.thebody.com/ apla/SeptOct02/ gold.htm, January 5,2004.

27. AIDS Vaccine: Flickers of Progress, but a long way to go; Providing HIV/AIDS Care in a Changing Environment; HRSA Care Action, March 2002. http://www.hab.hrsa.gov/publications/March2002.htm. January 14, 2004.

28. Max Essex. AIDS Vaccines for Africa. Lusaka, 12-16 September, 1999,http:///www.hdnet.org/Lusakal999-reports/440.htm,February 11,2004.

29. Salih Booker, and William Minter. (2000). AIDS in Africa: Is the World Concerned Enough? Great Decisions 2002; http:/// www.africa action.org/action/aids2002.htm, February 11, 2004.

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By Jonas E. Okeagu, Adegoke O. Ademiluyi, Joseph C. Okeagu, Chinyere I. Okeagu and Chinwe N. Onuoha*

* Jonas E. Okeagu, Ph.D. is Assistant Professor of Biology at Fayetteville State University, Fayetteville, North Carolina; Adegoke O. Ademiluyi, Ph.D. is Associate Professor of Geography at Fayetteville State University, Fayetteville, North Carolina; Joseph C. Okeagu, MD, a medical doctor at Owerri General Hospital, Imo State, Nigeria; Chinyere I. Okeagu, is a recent graduate in nursing from the University of North Carolina at Greensboro; and Chinwe N. Onuoha earned her MD from the medical school of the University of Port Harcourt, Rivers State, Nigeria.

Copyright Association of Third World Studies, Inc. Fall 2005

Source: Journal of Third World Studies

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