Back to drawing board for HIV vaccine search

The journey to search for HIV vaccine will take longer. This is after data showed that an investigational HIV vaccine regime did not provide sufficient protection against HIV infection.
The study known as Imbokodo (HVTN 705/HPX2008) was carried in a population of 2, 637 young women in Malawi, Mozambique, Zambia, Zimbabwe and South Africa who are at high risk of acquiring HIV.

Although the clinical trial for the vaccine has failed the efficacy, the vaccine was found to have a favourable safety profile with no serious adverse events.

“The Imbokodo vaccines did not contain HIV and the vaccines were therefore unable to transmit HIV to study participants. All women who joined the study were always provided risk reduction counselling on ways to keep healthy and prevent HIV acquisition,” reads the statement from Johnson & Johnson, the manufacturer.

In what has become an all too familiar outcome in the decades-long search for an effective human immunodeficiency virus, acquired immunodeficiency syndrome (HIV/AIDS) vaccine, yet another candidate has failed in a large-scale study.

“We have to fundamentally relook at what we’re doing,” said Glenda Gray, who heads the South African Medical Research Council and oversaw the protocol for the trial, which compared the efficacy of the vaccine to a placebo.

The study tested whether the Imbokodo vaccine regimen could prevent women from getting HIV. Over 2,000 women were enrolled and given four different shots over 12 months. The first jab, meant to ready (prime) the body to produce defences against the virus was administered followed by two booster shots. Vaccinations were completed in June 2020.

The results, announced on August 31, 2021 by J&J in a press release, found 63 infections in the placebo group compared to 51 in participants who received the vaccine whose efficacy was 25.2 percent—too low to make it useful.

Even though the vaccine, supported by both the U.S. National Institute of Allergy and Infectious Diseases and the Bill & Melinda Gates Foundation, was found to be safe and did not cause any harm, it had a wide “confidence interval” in that result, and it did not reach statistical significance.

Confidence intervals measure the degree of uncertainty or certainty that something like a vaccine will be effective.

“The trial held great promise that it might prevent HIV but findings showed the vaccine does not provide sufficient protection. There was some hint that it was partially working which is not strong enough to get it licenced hence the trial has been stopped,” explained Mitchell Warren, executive director, AIDS Vaccine Advocacy Coalition.

According to experts, so far, the Imbokodo study has produced “more” promising data than two other disappointing AIDS vaccine efficacy trials.

“We always hope that efficacy trials will show positive results that lead directly to new prevention options,” noted Mr Warren. “It is very disappointing that this particular vaccine candidate did not work in this trial, but the trial was well-conducted and got an answer quickly.

HIV remains a global threat, and a safe, efficacious, and accessible HIV vaccine is still needed to contribute towards curbing new infections and providing a durable end to the
pandemic. In 2020, there were 37.7 million people living with HIV, with 53 percent being women and girls. The UNAIDS estimates that about 6.1 million people did not know that they
were living with HIV in 2020.

J&J’s chief scientific officer, Paul Stoffels, says despite the failure, a second efficacy trial of a similar vaccine in a different study population will continue. That Mosaico trial, which is taking place in the Americas and Europe and started in 2019, involves 3,800 transgender people and men who have sex with men.

“This is in no way the end of the search for an HIV vaccine,” added Warren. “We still hope for a positive outcome from the ongoing Mosaico and PrEPVacc studies, which combines evaluation of experimental HIV vaccines and pre-exposureprophylaxis in East and Southern Africa from 2018 to 2023.

Warren spoke during a webinar attended by scientists and journalists which was hosted just few hours after the announcement of the HIV vaccine failure report, on August 31, 2021.

By Elizabeth Merab & Tebby Otieno


No sufficient protection, findings say of HIV vaccine candidate

Results from Phase 2B of the Imbokodo Study – carried out to test the efficacy and safety of a HIV vaccine candidate among women in five sub-Saharan African countries – shows that the vaccine candidate does not provide sufficient protection against HIV.

The study was conducted among 2,600 plus women in 23 sites across South Africa, Zambia, Zimbabwe, Mozambique and Malawi among women aged 18- 35 years at risk of acquiring HIV.

Discussing the findings at a Media for Environment, Science, Health and Agriculture (MESHA) briefing, Mitchel Warren, Executive Director of AVAC said that the efficacy of the vaccine was found to be at 25 percent.

“There was some hint that the vaccine was working very partially,” he said, “ but it is not strong enough to warrant the vaccine continuing in this trial because it is not good enough to get it licensed.”

Also known as the HVTN705/HPX2008, the study involved participants getting four different doses over the first 12 months of their participation.

“The first two were called prime, based on a cold virus, Adenovirus26. Then they received further boost- protein booster- to help stimulate the immune system. Half of the women received this combination, while the other half received four shots of a placebo, that didn’t have any active ingredient,” Warren explained, adding that the women were followed for 24 months after the final shot.

The Imbokodo study found that through 24 months of follow up, 63 of 1,109 participants who received placebo compared to 51 of 1,079 participants who received active vaccine acquired HIV.

In addition, it found that despite the low efficacy, the vaccine was safe and there was no adverse event reported.

There is a parallel trial ongoing dubbed the Mosaico trial being carried out on 3,000 men who have sex with men and transgender individuals in Latin America, US and Europe. The study uses a similar regimen with the same Adenovirus26 platform for the prime vaccine, but using a different form of protein boost.

“It is possible the vaccine could work differently because it is a different boost, addressing a different route of HIV transmission (anal route) or because it is in a different part of the world with different circulating HIV,” Warren said.

According to Warren, the Imbokodo study is a stark reminder of the need to develop a HIV vaccine and the need to scale up prevention products that are already at hand such as the condoms, Oral PrEP, injectable PrEP and vaginal ring among others.

“We have to go all in for the prevention products we have. We have to roll them out with urgency so that people can protect themselves today while we reorient the HIV research agenda,” he said.

The HIV vaccine was being developed in a public-private partnership by Johnson and Johnson in collaboration with National Institutes of Health, the Bill & Melinda Gates Foundation, and the HIV Vaccine Trials Network (HVTN) among others.

“HIV is a unique and complex virus that has long posed unprecedented challenges for vaccine development because of its ability to attack, hijack and evade the human immune system,” Paul Stoffels, Managing Director, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson said in a statement
during the release of the study findings.

“While we are disappointed the vaccine candidate did not provide a sufficient level of protection against HIV infection in the Imbokodo trial, the study will give us important scientific findings in the ongoing pursuit for a vaccine to prevent HIV.

We continue to stand in solidarity with people living with and vulnerable to HIV, and remain committed to furthering our research against this devastating virus,” he added.

Though it has been 37 years of existing with HIV, developing a vaccine for the virus has been an arduous task mainly due to the HIV strain diversity and the immune evasion strategies of the virus.

According to Ronald C. Desrosiers, Professor of Pathology, Vice-Chair for Research, University of Miami, in an article, the development of the vaccine is made difficult by the biological properties of HIV. This includes the ability of the virus to continuously replicate, to generate and tolerate many mutations in its genetic information as well as the ability to shield itself from recognition by antibodies.

Besides the Imbokodo study, there have been five other trials to find a vaccine for HIV. All of them failed since there was no protection against acquisition of the virus or lowering of viral loads for those infected.

Currently, the PrEPVacc studies are ongoing in Africa- Uganda, Tanzania, Mozambique and South Africa- to test efficacy of a two experimental combination of HIV vaccine regimen while also comparing the effectiveness of a new form of oral PrEP (Descovy) against Truvada. The study which includes both men and women aged 18-40 years at risk of HIV
started in 2018 and will end in 2023.


By Sharon Atieno



The search continues, say scientists after setback on HIV vaccine trial

Scientists have played down fears that they may call off the search for a HIV vaccine after a recent study failed to reduce the overall risk of HIV acquisition among women
in five sub-Saharan African countries.

Noting that even though the study did not find the product under test effective as a HIV vaccine, hope still lies on other major trials still ongoing globally.

A major vaccine currently being tested at scale is the Mosaico trial, which is testing a vaccine among transgender people and gay men and other men who have sex with men in the Americas and in Europe.

The scientists were addressing journalists after Johnson & Johnson and partners announced that the Imbokodo study, a large-scale HIV vaccine proof-of-concept trial also known as HVTN 705/ HPX2008, did not significantly reduce the overall risk of HIV acquisition among women in five sub-Saharan African countries.

The report indicated that the vaccine trial, which was being conducted among 2,637 young women aged between 18 and 35 years in five countries (Zimbabwe, South Africa, Malawi, Zambia and Mozambique) did not provide sufficient protection, with a paltry 25.2 percent efficacy attained.

In a statement to the media, Paul Stoffels, Managing Director, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson thanked the women who participated in the trial and the company’s partners.

“We are extremely grateful to the women who volunteered for the Imbokodo study, and to our partners, including the people on the frontlines, all of whom are contributing every day to this enduring quest to make HIV history,” he said.

“While we are disappointed that the vaccine candidate did not provide a sufficient level of protection against HIV infection in the Imbokodo trial, the study will give us important scientific findings in the ongoing pursuit for a vaccine to prevent HIV,” he added.

“We must apply the knowledge learned from the Imbokodo trial and continue our efforts to find a vaccine that will be protective against HIV,” added Anthony
Fauci, director of the US National Institute of Allergy and Infectious Diseases which co-funded the study.

Speaking during a media science café by Media for Environment, Science, Health and Agriculture (MESHA), AVAC Executive Director Mitchell Warren said the HIV vaccine trial was not a total failure. Warren said the trial is important for science research as it directs the next step in learning because it gave quick results and clues that can be used in the other ongoing vaccine trials.

“The Imbokodo study was a beautifully designed study that was safe and well conducted even with the disappointing results,” he said.

Warren said HIV remains a global threat, and a safe, efficacious and accessible HIV vaccine is still needed to contribute towards preventing new infections and
providing a durable end to the scourge. He said there is still hope in the fight against HIV, with two other major trials still ongoing in Africa.

“This is in no way the end of the search for a HIV vaccine. We still hope for a positive outcome from the ongoing Mosaico and PrEPVacc studies,” he said.

The AVAC director further noted that now more than ever, the vaccine field needs diversity and creativity and even more collaboration interns of research and product delivery.

He said there was a need to scale up the delivery of available, safe and effective HIV prevention options, including male and female condoms, voluntary medical male circumcision and daily oral PrEP.

“Other additional prevention options are nearing availability, including the dapivirine vaginal ring and injectable cabotegravir, and several next-generation PrEP options are now entering advanced clinical trials,” he added.

His sentiments were echoed by Ntando Yola, a health advocate, who called for collaborated efforts by all stakeholders in coming up with correct messaging in communicating the science of health.

“How effective we are in sending science health messages to the public will help in curbing misinformation on vaccines not only HIV related,” said Yola.

For 40 years, scientists have been searching for an effective HIV vaccine in vain, given the mutating nature of the disease and the various strains circulating in different regions globally.

In February last year, the United States National Institutes of Health announced that its HVTN 702 clinical trial of an HIV vaccine, also known as Uhambo, had been stopped. While
no safety concerns were found during the trial, the independent data and safety monitoring board found that the vaccine was ineffective in preventing HIV transmission.

The trial, conducted at 14 sites across South Africa, followed more than 5400 HIV-negative 18–35-year-olds over 18 months.

The participants received six injections during the six-month period, either the vaccine or a placebo. An analysis undertaken after at least 60% of the participants had been in the study for more than 18 months showed that there were 129 HIV infections among the people who had the vaccine, while 123 people who had the placebo became infected.


By Christine Ochogo


Search for an AIDS vaccine lands me my first ever media science café

A message on my phone from Aghan Daniel, the secretary of MESHA ( on Wednesday, February 5, 2020 awakened my thoughts about the future of the world without a HIV vaccine.
Aghan was inviting to me to attend a two hour media science café at a Nairobi Hotel. In the invite, he simply stated that the meeting had been called to discuss vaccine research in the context of the halt of HVTN702 clinical trials.
As I sat in my university room, two things came to my mind. One, what is a media science café? Two, will I understand what the scientists will talk about given that they used complex terms?
Anyway, I conjured up courage and arrived at the venue 30 minutes before time. Then the introductions were done – and I was happy because I was seeing big names that I had only got to meet through bylines in the newspapers or heard their voices on radio! There was Angela Oketch of the Nation, Ann Mikia,a renowned radio personality in Kenya, Mike Mwaniki, a veteran journalist and Violet Otindo, whom I had only seen on TV, among others.
When the presentations started, Dr Kundai Chinyenze, Executive Medical Director, IAVI stepped forward and showed very simple slides using ordinary language in most of her talking points –she was very conscious of what could be technical and she explained them using a language that me, a non-science student easily understood.
Her topic was simple, HIV vaccine research efforts and IAVI’s role in the search for a safe, effective, affordable and globally accessible vaccine.
Then came Professor Omu Anzala from Kenya AIDS Vaccine Initiative (KAVI-ICR), University of Nairobi spoke on their roles in HIV vaccine research and prevention in Kenya.
These included clinical trials, research in communicable diseases, non- communicable diseases and the knowledge translation through public forums and targeted events like the science café, that I was privileged to attend for the first time. Prof Anzala spoke simple things off head without any presentation. He was in his element in his simplicity.
Mrs Rosemary Mburu, Executive Director, WACI Health talked on the need for the HIV vaccine. “We can end HIV without a vaccine but we cannot sustain the virus without a vaccine,” she said. She also urged for meaningful engagement of local communities for successful research and clinical trials.
To wind it up, a HIV champion, Ms Inviolata Mmbavi, Executive Director, International Community of Women Living with HIV – Kenya Chapter narrated her story of living with the virus for the last 30 years. “When you test HIV positive life will never be the same again,” she told us. She noted that the first drugs that were administered to her, almost killed her.
“That drug was a monster,” she said looking at Prof Omu Anzala whom she noted had started her on ARVs nearly three decades back and yet the two had never met again till today’s science café brought them together.
“Ladies and gentlemen, I have hope that a vaccine, to be only administered once in a human being’s life, will be found,” she said, almost tearfully.
She said that taking drugs daily is not a walk in the park and urged the researchers not to tire in their search for an AIDS vaccine. I gained a lot from this café and learnt that a lot of research is still being done in the quest to find an AIDS vaccine. This will definitely bring smiles back on the faces of those who are distraught because HVTN stalled.
The trials that are on-going include Imbokodo (Phase 2B/3) trial HVTN 705 which is a Mosaic Vaccine Aiming at Protection Against wide variety of global HIV strains. Dr Kundai said that HVTN 705 is a trial in women in five African countries of South Africa, Malawi, Zambia, Zimbabwe and Mozambique. The trial results are expected in 2022. Besides, up next is the PrEPVacc Trial Phase 2b trial which is testing 2 vaccines regimens to prevent HIV infection and compare a new kind of daily pill for pre-exposure prophylaxis (PrEP), Descovy vs the currently used Truvada. Importantly, this trial tests 2 vaccines regimens to prevent HIV infection and compare a new kind of daily pill for pre-exposure prophylaxis (PrEP), Descovy vs the currently used Truvada. Dr Kundai told us that this is the first efficacy vaccine trial that includes daily oral PrEP in its design in both men and women.

She added that it is planned to start later this year in Uganda, Tanzania, Mozambique and Kenya.
As I walked back to the university that day, not only was my fear of scientists slayed but I also felt tantalized by a few statements made at the café. 1. “Without HIV vaccine, we will not end AIDS.” – Dr Kundai Chinyenze. 2. “Can we end AIDS without a vaccine? Yes! But we cannot sustain HIV without a vaccine.” – Mrs Rosemary Mburu and 3. “When you test HIV positive life will never be the same again.” – Ms Inviolata Mmbavi, HIV champion.
The writer is a first year journalism student at the University of Nairobi.



Why we need HIV vaccines like yesterday

More than 20 years ago, just after I had completed my secondary education, I was diagnosed with HIV. At that time, I thought I now had full self responsibility to my life. I had dreams, just like any other young person. This was the worst news I heard at that moment.

My life came to a standstill for awhile. Everything around me was now dictated by my diagnosis. My education, my career and family dreams were shattered and my parents and siblings were affected even more than myself. Ever since then, life has never been normal, It is not normal, It will never be normal for me even if a cure is found.

I have been to hell and back because of HIV on all fronts. Most notable and physical was my onset of treatment. Twice, I have reacted very badly to medication to the point of almost losing my life. At one point, I thought death would be more relieving than the pain and discomfort I was feeling. I am alive today mainly for having had access to competent, quick medical attention and strong family support at that time. In my more than 20 years work in the HIV field, I do not know of any HIV positive individual who has had it easy both socially and medically. I know some that have even died due to drug reactions, stigma and late diagnosis and lack of access to care and support. We musk a lot; because that is what society wants to see or wants us to portray.


Why am I saying all this?

I want to repeat, it is not normal. I do not wish this to happen to our children who have dreams and a full life ahead of them. I would not wish HIV infection to happen even to my worst enemy. It is for these reasons I am joining the prevention advocates. I will do whatever it takes within my ability to speak out and support prevention efforts to stop any single HIV infection where I can. I will support the HIV vaccines initiative because if it succeeds, it will be one of the biggest breakthroughs in the fight against HIV.

It is no longer about me People spoke for us; I am alive today because of the many voices that stood up for us – people living positively with HIV (PLWHIV). My immediate family takes the biggest credit. They read anything and everything they could come across that would enable them to help me and understand me.

But it still has never been normal and it will never be for me. As an existential fact, we are alone. Many a times I am alone, pain, drugs swallowing, loss of appetite….I am alone.

This can, and could have been prevented. I am going to spend the remaining part of my life, advocating for all forms of prevention…. but education and vaccines are going to take centre stage of my advocacy work. For we all know, PREVENTION IS BETTER THAN CURE.

The face of HIV today is young people. As a mother, and as a person who got infected at that tender age, the news about new HIV infections among young people churns my stomach.

I look forward to seeing how advocates are going to be engaged in the HIV vaccine initiatives and I am more than happy and willing to take on this assignment very seriously to let communities know and understand the importance of HIV vaccine and prevention.

Inviolata Mwali Mmbwavi is the National Coordinator International Community of Women Living with HIV Kenya Chapter (ICW-K)