Vaccine Briefs

New Report On AIDS as Security Threat

Unchecked spread of the AIDS epidemic in five countries could have grave destabilizing effects with global consequences, said a September report produced by the National Intelligence Council (NIC), a panel of experts that advises the Central Intelligence Agency and other US government agencies. The report focused on China, India, Nigeria, Ethiopia, and Russia, which are in relatively early stages of the epidemic, and projected that they could cumulatively have 50-75 million HIV-infected people by 2010, at which time the NIC predicts 100 million infections worldwide.

The paper has received particular attention because its projections exceed other published estimates. UNAIDS does not provide projections for individual countries, but has released a global estimate of 60 million by 2010. One reason for the discrepancy is the difficulty of predicting the course of early epidemics, when infections are still concentrated in high-risk populations. The NIC projections are based on “worst-case scenarios” in which the epidemic spreads into the general population. UNAIDS is currently providing countries with training in projection methodology, and these forecasts may be included in future UNAIDS reports.

United Nations Updates Guidelines on HIV/AIDS and Human Rights

In September, 2002, the United Nations issued revisions which ensconce the right to treatment for HIV/AIDS in the International Guidelines on HIV/AIDS and Human Rights. Created in 1998 by the Office of the High Commissioner for Human Rights and UNAIDS, the guidelines are not legally binding, but can be used as a “cudgel” by groups and individuals seeking to spur governments into stronger action, says Chris Beyrer of the Johns Hopkins School of Public Health.

The new Guideline 6 makes an unprecedented call for specific actions from governments, including the creation of concrete national plans with timelines for progressing to universal, equitable access to HIV/AIDS-related treatment, care and support. Commentary accompanying the guidelines lists antiretrovirals, medications for opportunistic infections, condoms, clean syringes, vaccines and microbicides (when approved) among those commodities that governments must commit to providing. Beyrer says that the new guidance puts the needle exchange policies of many governments—including that of the US—in a new light. “What this means is that a federal ban on needle exchange is in violation of human rights principles,” he says. Go to International Guidelinesfor more information.

Phase I DNA Vaccine Trial to Launch in late 2002

By the end of 2002, a Phase I trial (HVTN 045) will begin the process of clinically evaluating a DNA/MVA prime-boost strategy developed by Harriet Robinson (Emory University, Atlanta). HVTN 045 will test the DNA vaccine (which contains the gag, pol, env, vpu, tat and rev genes from HIV-1 subtype B) in 30 volunteers at three domestic sites of the US HIV Vaccine Trials Network. Volunteers will receive two injections (days 0,56) with either 0.3 or 3 mg DNA. The MVA vaccine will be tested separately in HVTN 046. Depending on the timing of the second trial, says Robinson, the prime-boost combination will be tested either by boosting consenting participants of HVTN 045 with MVA or through a new DNA/MVA trial.

Robinson’s vaccine has been shown to protect monkeys against challenge with SHIV89.6P, with 23 protected monkeys still healthy and maintaining low or undetectable viremia for over two years. Future plans include development of clade C and A versions of this vaccine, as well as an ABC “multiclade” version.

Global Fund Board Meets as Difficulties Mount

The third board meeting of the Global Fund to fight AIDS Tuberculosis and Malaria (10-11 October) began with Fund Director Richard Feachem warning that, without new resources, the Fund will be bankrupt by 2003. The Fund currently has approximately US$2 billion in pledges, with $500 million in hand; the first round of grants (made in April 2002) exceeds $600 million. According to Feachem, the Fund has received grants “worthy of funding” in excess of $8 billion.

The Fund drew criticism from some quarters for its announcement that it will scale back to two grant cycles per year instead of three, with the next round scheduled for early 2003. However, the Board’s decision to support the use of high-quality generic drugs was cheered by AIDS activists and advocates as a significant step towards increasing access to affordable antiretrovirals in resource-poor settings.

US FDA Issues First Official Guidance on Pregnancy Registries

In September, the US Food and Drug Administration (FDA) issued its first official guidance document on pregnancy exposure registries that would gather information on women who become pregnant during clinical trials. Most pharmaceuticals, including vaccines, are licensed with little information about effects on pregnant women or fetuses, since pregnant women are generally excluded from trials or dropped if pregnancy occurs. The guidance recommends registries in several situations, including when “inadvertent exposures to the medical product in pregnancy are or are expected to be common, such as when products have a high likelihood of use by women of childbearing age”—a likely scenario for AIDS vaccines. The guidance states that the FDA (whose decisions influence those in many developing countries) may ask for pregnancy exposure registry as part of Phase IV post-marketing studies. The complete guidelines are available online at www.fda.gov/cber/gdlns/pregexp.htm

DNA-MVA Trials Approved in Kenya

Kenyan regulatory authorities approved two Phase I trials that will advance the DNA-MVA prime-boost strategy developed by a collaboration among Oxford University, the University of Nairobi and IAVI. The two trials—one with MVA alone, the other using a DNA-MVA prime-boost protocol, will gather information about optimal dosing, immunization route and schedule. The trials will enroll 70 people and are expected to begin before the end of 2002.