Frequently Asked Questions
- FAQ On HIV Vaccines
- NPT short quizzes
A vaccine is a preparation that teaches the body to recognize and defend itself against bacterial and viruses that can cause disease. A vaccine for the human immunodeficiency virus(HIV the virus that causes AIDS), will protect uninfected people against HIV in avariety of ways e.g by stimulating the body's immune system of fight and kill HIV as soon as it enters the body
Currently, there are no effective HIV vaccines available. However, there are several possible vaccine that may work. Some are undergiong animal trails while some are alreasy undergoing clinical (human) trials. The development of a vaccine takes a while. This is as to ensure it is save and effective. An effective HIV vaccine will cause the body defense system to oercome the virus if it enters the body.
Vaccine development is a lengthy process of testing ideas and products. The concept are tested and improved many times before they are ready to be tested in humans. Initial tests are done on the product in the laboratory and in animals. If the candidate accine is promising(when extensive studies in animals show no significant side effects), a pkan is then developed for its test in humans. This plan is subbmitted to appropriate national regulatory bodies in order to futher ascetain its safety in humans.
No, they cannot. The candidate vaccines presently undergoing trials are artificially made and carry no risk of transmminting HIV. They do not cointain killed or weakened HIV, or any material from HIV-Infected individuals or form individuals found to be resistant to HIV. Neither do they contain blood or blood product.
Any effective vaccine developed would be made available first to populations with the highest HIV incidence, especially those who have contributed to vaccine development through partcipation in trials. Many organizations all over the world are currently developing strategies to ensure that caost does not become a barrier to access to an effective HIV vaccines, when developed.
it is important that Nigerian scientist, reseacher and advocates work in collaboration with international patners to develop a safe and affordable preventive HIV vaccine. This would enable the country develop and test HIV vaccine that are specifically designed to be used in West Africa and Nigeria in particular.
Clinical trials of a few candidate vacancies are to start in Nigeria in 2004 and 2005. Nigeria medical research institution will conduct come of the trials. the nigeria government is working through the national Institute for Pharmaceutical Research and Development (NIPRD) Abuja and other instituitions to develop a home grown HIV vaccine. Already, the goverment has drawn up a HIV vaccine Developement Plan.
The various stages of clinical (human) trials would involve several volunteers who wolud willingly participate in the testing of these candidate vaccines. You can plan to be a volunteer whan the trial starts. there are several thousands of volunteers for such trials all over the world with whic you can network.
However, before the trials start, you can lend your voice, energy and time to advocate the the Nigerian Government keep to its schedule for the development of a vaccine for Nigeria, as contained in the the national HIV Vaccine Development Plan. Government must also implement aggreements and commiteement it has made with patners at regional and international level towards ensuring speedy development of a HIV vaccine. it is in the intrest of every Nigerian thet the Goverment implements the National HIV Development Olan scrupulously and on time. You can contact NVHMAS for more informationon how you can join in the global advocacy for the development of a safe and effective vaccine for HIV
NHVMAS (pronounced a 'navmas') is an acronym for the New HIV Vacccine and Microbicides Advocacy Society. It is a civil society group commited to mobilizing popular participation and public support for vaccine and microbicide research and the development in nigeria. Its miccion is to halt the spread of HIV/AIDS in Nigeria by ensuring the availabilty of safe, effective acceptable and affordable HIV vaccine and microbicides products for all Nigerians. NHVMAS works to ensure the proactive participation of Nigerian and Nigerians in Global effort for the development of HIV vaccine and microbicides. it recognises that there is an ethical imperative to seek, as urgent as possible an effective and acceptable vaccine to complement other existing and emerging provention strategies
NHVMAS is oppen to all Nigerians and seek to patnet with as many group as possible. You can contact NHVMAS for more infomation on how you can join in the national advocacy for the development of a safe effective and affordable HIV vaccine that can put a halt to the HIV/AIDS epidemic
Uganda has been committed to HIV/AIDS vaccine research as an integral part of a comprehensive response to the epidemic since the early 1990s. The country launched the first AIDS vaccine trial in sub-Saharan Africa in 1999. Its first AIDS Vaccine Plan for Uganda was developed in 1992. This was revised in 2001 and has now been updated in light of recent developments. The focus of its HIV Vaccine plan is to develop a HIV Vaccine relevant for Ugandans and others.
South Africa, with its scientific capacity, good infrastructure and high HIV incidence rates, is ideally positioned to conduct large-scale HIV prevention trials. The HIV Prevention Research Unit of the South African Medical Research Council – one of multiple centres with capacity to conduct HIV prevention trials - conducted four phase III (CS3, MIRA diaphragm study, Carraguard, MDP 301) and one phase IIb (HPTN 035) trials of women-initiated HIV prevention options in KwaZulu-Natal between 2003 and 2009. A total of 7046 women participated.
The CAPRISA site also enrolled 889 women for its 1% tenofovir microbicide study. The study showed that a 1% tenofovir gel was 39% effective in preventing HIV infection in women when applied topically in the vagina.
There are about 15 sites in South Africa that was engaged in VOICE, iPrEx and FEMPREP studies; studies that will evaluate oral and topical (microbicide) ARV based prevention tools in women, and MSMs. These studies are currently enrolling participants.
It continues to conduct male circumcision related studies at the Orange farm. The first trial recruited 3274 uncircumcised men. The study population were randomised to a cicumcision arm or the non circumcision arm. The study showed 60% protection from HIV infection for men who were HIV negative and engaged in vagina sex. The study was discontinued early by the DSMB due to the strong evidence of benefit from male circumcision. The site continues to conduct male Circumcision projects based on the result of this study. An example is the Bophelo Pele Project.
South Africans were also engaged in the Pambili HIV Vaccine trial and had enrolled 801 participants prior to discontinuation based on the observed associated increase HIV infection in the STEP trial. The STEP trial was using the same kind of candidate vaccine as the Phambili trial. The Phambili trial was conducted in the Perinatal HIV Unit at Chris Hani-Baragwanath Hospital. This site was also one of the eleven sites for the Niverapine study for prevention of mother to child transmission of HIV infection. The site was also engaged in the Partners in Prevention Study that evaluated the efficacy of twice daily use of acylcovir by individuals co-infected with both HSV-2 and HIV to reduce the risk of transmitting HIV to their uninfected partners. The study was conducted amongst serodiscordant couples.
South Africa is also to engaged in the iPrEx trial where participants use Truvada once a day (PreP) to see if it will reduce HIV infection amongst MSMs. This study is collaborating with the Desmond Tutu Foundation.
Peru took part in the STEP vaccine trial. The Step trial showed that HIV infection increased amongst participants who were receiving the active ingredient (not the placebo) especially amongst men who were Ad5 positive and uncircumcised. The trial was discontinued prematurely by the DSMB because of this. Other countries involved in that trial were US, Australia, Brazil, Canada, Haiti, Jamaica, Puerto Rico and Dominic Republic. Trial was discontinued in Spetember 2007.
Peru was also involved in the HSV 2 suppression study conducted by University of Washington. The study examined if the use of Valacyclovir in HSV2 positive individuals – an antivirus used to manage HSV 2 infection – would reduce HIV infection possibility. It was designed as a proof of concept study. 20 MSM were recruited into the study. The study showed no evidene of benefit. The study result was announced in 2008.
Peru is also involved in the iPrEx trial where participants use Truvada once a day (PrEP) to see if it will reduce HIV infection amongst MSMs.
The South African study was conducted at the Oral Farm. It recruited 3274 uncircumcised men. The study population were randomised to a cicumcision arm or the non circumcision arm. The study showed 60% protection from HIV infection for men who were HIV negative and engaged in vagina sex. The study was discontinued early by the DSMB in 2005 due to the strong evidence of benefit from male circumcision.
Similarly, randomized controlled clinical trials were conducted in Kenya and Uganda and was stopped in 2006 after interim analyses found a statistically significant reduction in male participants’ risk for HIV infection from medical circumcision. The men who had been randomly assigned to the circumcision group had a 60% (South Africa), 53% (Kenya), and 51% (Uganda) lower incidence of HIV infection compared with men assigned to the wait-list group to be circumcised at the end of the study.
In an earlier large prospective study of couples in Uganda, in which the male partner was HIV infected and the female partner was initially HIV-seronegative, the infection rates of the female partners differed by the circumcision status and viral load of the male partners. If the male’s HIV viral load was <50,000 copies/mL, there was no HIV transmission if the man was circumcised, compared with a high transmission rate if the man was uncircumcised. This showed a significant protective effect; infection were 42% lower for circumcised men. When viral load was not controlled for, there was a nonsignificant trend toward a reduction in the male-to-female transmission rate from circumcised men compared with uncircumcised men. Such an effect may be due to decreased viral shedding from circumcised men or to a reduction in ulcerative STDs acquired by female partners of circumcised men. The study was reported in 2000.A clinical trial in Uganda to assess the impact of circumcision of HIV positive men on male-to-female transmission reported that, its first interim safety analysis showed a nonsignificant trend toward a higher rate of HIV acquisition in women partners of HIV-seropositive men in couples who had resumed sex prior to certified postsurgical wound healing, and did not detect a reduction in HIV acquisition by female partners engaging in sex after wound healing was complete.
There are epidemiological evidence from over 40 studies which shows that male circumcision provides significant protection against HIV infection; circumcised males are two to eight times less likely to become infected with HIV. Furthermore, circumcision also protects against other sexually transmitted infections, such as syphilis and gonorrhoea, and since people who have a sexually transmitted infection are two to five times more likely to become infected with HIV, circumcision may be even more protective. Compared with the dry external skin surface, the inner mucosa of the foreskin has less keratinization (deposition of fibrous protein), a higher density of target cells for HIV infection (Langerhans cells), and is more susceptible to HIV infection than other penile tissue in laboratory studies. The foreskin may also have greater susceptibility to traumatic epithelial disruptions (tears) during intercourse, providing a portal of entry for pathogens, including HIV. In addition, the microenvironment in the preputial sac between the unretracted foreskin and the glans penis may be conducive to viral survival.The CAPRISA 004 study proved that 1% tenofovir gel when placed in the vagina 12 hours before and 12 hours after vagina sex reduced the chance for HIV infection. The study was a proof of concept study – a study to show that ARV based gel when applied into the vagina could protect from HIV infection. It is not an efficacy study.
The female condom is a thin sheath or pouch worn by a woman during sex. It entirely lines the vagina and helps to prevent pregnancy and sexually transmitted diseases (STDs) including HIV. Two types of female condom are available.
The FC female condom has been available in Europe since 1992 and was approved by the US Food and Drug Administration (FDA) in 1993. It is a polyurethane sheath or pouch about 17 cm (6.5 inches) in length. At each end there is a flexible ring at the closed end of the sheath, the flexible ring is inserted into the vagina to hold the female condom in place. At the other open end of the sheath, the ring stays outside the vulva at the entrance to the vagina. This ring acts as a guide during penetration and it also stops the sheath bunching up inside the vagina.There is silicone-based lubricant on the inside of the condom, but additional lubrication can be used. The condom does not contain spermicide.
VA w.o.w. Condom Feminine (or VA for short) has been distributed as part of HIV prevention efforts in South Africa since 2004. Like most male condoms, the VA is made of latex. When not stretched it is much shorter than the FC – around 9 cm (3.5 inches) – though it is highly elastic. It has a rounded triangular frame at the open end and a sponge inside the closed end, which helps to anchor it inside the vagina. The VA is lubricated and does not contain spermicide. Oil-based lubricants should not be used with this female condom as they can damage latex.
The first generation of new HIV prevention technologies will likely be partially effective. It will therefore be important to compliment or reinforce HIV prevention through sex by the use of condom in combination with these products.
The CAPRISA 004 is the first ever trial to show that an ARV based microbicde is able to reduce HIV infection when applied topically to the vagina. The study was conducted in one rural and one urban site in South Africa. 889 women were recruited into the study. The study showed that the gel, when applied 12 hours before and 12 hours after vagina sex, was 39% efficacious in reducing HIV infection.
People are different and what works for one person in one situation may not be applicable for another person in another situation. Also, people change over time and may need different options at different stages of their life. Finally, public health emphasizes that multiple prevention options should be available in order to provide a comprehensive response to the epidemic.
It is a process by which a participant voluntarily confirms his or her willingness to participate in a particular study after having been informed of all aspects of the trial that are relevant to the participant’s decision to participate. Informed consent is a continuing process throughout the study life-cycle which helps to ensure participants understand the purpose, procedure, benefits and risk of the research study.
The minimum prevention package provided to participants in HIV prevention trials for sexual transmission should include intensive condom and safer sex counseling, access to free male and female condoms, and regular screening and treatment for STIs. All HIV prevention trials make effort to ensure participants have access to currently available HIV prevention tools. Efforts are made to prevent exposure to HIV infection. There should therefore be intense counselling on regular and correct use of the male and female condoms. Condom use should also be demonstrated and condoms made freely available for study participants and their partners. Participants are also regularly screened and treated for STIs. Ideally the study sites should also make this service available to sex partners of study participants free.
The conduct of HIV prevention research usually lead to the improvement and upgrade of infrastructures because of the need to generate data that are of high quality, dependable and useable. This often implies the upgrade of laboratories and study clinics in addition to the continued training of study staff. This translates to improved quality of health care services for trial participants.
The Nigerian penal code does not prohibit one from being gay or lesbian. Gay men or lesbians cannot be arrested for having sexual feelings for a person of the same sex – their sexual feelings and sexual identities are not illegal – but sexual activities between individuals of the same sex are illegal. The penalty is seven years in prison. Section 214 of the penal code states that “any person who has carnal knowledge of any person against the order of nature ……. is guilty of an offence and is liable for imprisonment.’’ Carnal knowledge is not defined, but the accepted definition is ‘sexual intercourse against the order of nature’, which is defined as anal penetration, and the other party involved may be a man or woman. This has been interpreted by the courts to prohibit sexual relations between persons of the same sex, whether male or female.
This code was derived from the Briish constitution. Britain has since expunged this part of its constitution as it is recognised as an infringement on the individual’s human rights who should have the right to freedom of sexual expression amongst consenting adults.
The risk of HIV amongst gay men and MSM arises from unprotected anal sex in which there is insertion of a man's penis into his partner's rectum. Anal penetration can be a source of physical discomfort. If penetration into the anus is forced, injury is possible. It is helpful to use a lubricant liberally and to relax and gradually dilate the sphincter by gentle manual stimulation before attempting penetration. HIV can be transmitted through anal sex, especially anal intercourse. The risk of HIV transmission is greater than in vaginal intercourse because the lining of the rectum tears more easily than the vagina. The resulting skin breaks and bleeding increase the possibility of the transmission of bodily fluids containing the virus that causes AIDS. STIs can also occur in the anus and thus increase the risk of HIV infection through anal sex. Condoms and lubricants should therefore be used when engaging in anal sex.
Anal sex is associated with increased risk of HIV because the lining of the rectum tears more easily than the vagina. The resulting skin breaks and bleeding increase the possibility of the transmission of bodily fluids containing the virus that causes AIDS. STIs can also occur in the anus and thus increase the risk of HIV infection through anal sex.
The risk for HIV infection is greater for the partner who is the receptor (who is penetrated by the penis) due to the increased risk for tear of the lining of the rectum.Although anal sex is often thought of as a strictly homosexual activity, many heterosexual couples enjoy it too. Anal penetration can be pleasurable, but it can also be a source of physical discomfort
Approximately 5 –10% of the world’s general population engages in anal intercourse. Among women with multiple risk behaviours for HIV acquisition, an estimated 30 –50% engage in anal intercourse.
Anyone who engage in anal sex is encourged to use a lubricant to easy physical discomfort and tear of the rectal lining. Having a lubricant like substance that has the additional advantage of protecting against HIV infection will be a welcome development. A safe, effective, acceptable and accessible rectal microbicide could provide that profile. Rectal microbicides could offer both primary protection in the absence of condoms and back-up protection if a condom breaks or slips off during anal intercourse.
A rectal microbicide developed as a lubricant will help the ease of penetration. It will be an addition feature for lubricants and a most welcome development for many men and women who engage in anal sex.
Some people empty the rectum with a disposable enema before anal intercourse. A rectal microbicide in the form of an enema will be an added advantage for these people. A suppository will also have its advantage as a long term delivery mechanism for product.
The field of rectal microbicide (RM) research is more vibrant than ever. Researchers are developing and testing products in laboratory tests and animal studies. Safety trials look to see if the RM does not cause harm and is well tolerated. One safety trial has been completed, and other safety trials have begun. Once candidate RMs are shown to be safe, they can move into efficacy trials to determine if they actually work to prevent HIV infection.
Acceptability and behavioural studies help determine the characteristics of products people would most likely use, and determine who is engaging in AnaI sex. Baseline studies investigate what normally happens physiologically during Anal sex. Formulation studies explore how different chemicals and substances would be put together to create a safe and effective rectal microbicide. Distribution studies ask the question - where do rectal microbicides need to go in the human body?
Lubricant safety studies seek to establish whether currently available lubricants are safe to use rectally. The lubricants being tested are not designed to specifically block the transmission of HIV, but it is important to know whether they are causing any harm.
There are so many names of studies you have to know in the field. Many of us simply cannot keep track of them. For some of us, it puts us off – HPTN 035, CAPRISA 004, MTN 003, MDP 301, IAVI 001, RV 144. What does this all mean?
I call them NPT research jargons. They are ways that researchers within their institutions/organisations/Network keep track of their studies. For the researches, the letter – HPTN, MTN, IAVI, IPM – tells you the institution conducting the study. The figure that apears after this is helps the institutions/organisations/Network keep track of the number of trials they are conducting. For example, CAPRISA 004, which is the name (or label) of the recently reported study of a microbicide gel using 1% tenofivr, means that microbicide study is the 4th study (004) being conducted by the CAPRISA. The MTN 003 study is a phase 2B study looking at the efficacy of ARV based vagina gel and PreP. The label MTN 003 simply means this study is the third study being conducted by the Microbicide Trial Network (MTN).
A few of these institutions/organisations/Network are trying to be more label friendly. For example, the MTN 003 study is also called the VOICE study. VOICE is the acronym for Vaginal and Oral Intervention for the Control of the Epidemic. So the MTN 003 study is also called the VOICE study.