Date: August 28, 2024
Location: Evergreen Recreation Center in Masaka City
Coordinator: Malik Fahad Jjingo
Attendees: 19 Journalists
MRC Dissemination Meeting in Masaka City
The MRC held a dissemination meeting at the Evergreen Recreation Center in Masaka City to brief journalists about the PrEPVacc trial—a Phase IIB, three-arm, two-stage HIV prophylactic vaccine trial with a secondary randomization to compare TAF/FTC with TDF/FTC as pre-exposure prophylaxis. The engagement, which attracted journalists from Masaka City, took place on August 28, 2024.
The meeting began at 10:00 AM and concluded at 12:30 PM, with over 19 journalists from various media houses in attendance.
Speakers:
- Vincent Basajja – Coordinator of Community Engagements at MRC Masaka Center
- Sylvia Masawi – Researcher at MRC Masaka Center
- Hakim Mawanda – IT Officer at MRC Masaka Center
- Olivia Nakavuma – Data Clerk at MRC Masaka Center
List of Journalists in Attendance:
Name Contact station
1 Malik Fahad Jjingo 0771413881 Radio One
2 Davis Buyondo 0782685292 New vision
3 Gertrude Mutyaba Lillian 0757480821 Spark tv
4 Nabukalu Matilda 0701235064 Centenary fm
5 Tony Kalyango 0751809940 Daily monitor
6 Joseh Kiyimba 0751032621 Karo FM
7 Musisi Fred 0758746836 Starfm
8 Milly Nayiga 0750967145 Spantia
9 Namawejje Olivia 0704138020 Centenary FM
10 Mildred Nakasanya 0759156416 Radio Buddu
11 Nsubuga Robert 0782918702 BBS TV
12 Matia Ssebufu 0789997727 Buddu fm
13 Prosy Kabanda 0756326078 Buddu FM
14 Magret Kayondo 0782962333 Simba fm
15 Denis Kawooya 0754849597 Crest FM
16 Derrick Jjuko 0754609695 Centenary fm
17 Kigongo Musa 0702388421 CBS emanduso
18 Hanifa Namuwonge 0758054763 Bukedde Radio
19 Richard Kyanjo 0751023218 Bukedde paper
20 Male John 0700779622 CBS Emanduso
The engagement began with a word of prayer led by Kalyango Antonio, a journalist with the Daily Monitor, followed by participant introductions. Vincent Basajja informed participants about the main purpose of the dissemination meeting before explaining the processes researchers go through while conducting clinical trials.
Basajja urged journalists to report cautiously, avoiding the victimization of people living with HIV/AIDS and those at high risk of contracting the virus. He cited a recent misleading media report about the prevalence rate on Mpuga Island as an example. Basajja then presented the results of the PrEPVacc trial, noting that the vaccine did not pass the trial.
He introduced the participants to the PrEPVacc trial partners, including coordinating partners such as Pontiano Kaleebu and Eugene Ruzagira from MRC/UVRI & LSHTM, Uganda, and other key figures from institutions like Imperial College, UK, IAVI-Kenya, and CHUV/EVF, Switzerland. The trial was led by African researchers based in Entebbe, Uganda, and supported by 15 partners from Africa, Europe, and the US, aiming to build long-standing HIV prevention partnerships.
The background of the trial dates back to 2017, when vaccine candidates, previously tested in Europe, the US, and Africa, were ready for clinical efficacy testing. With early access to treatment and PrEP increasing, the impact on HIV incidence (estimated at 4 per 100 person-years in 2017) was unclear, leading to the commencement of a registration cohort (2018-2023) in which overall HIV incidence was 2.9 per 100 person-years.
The study’s objectives were to assess the safety and efficacy of two HIV-1 prophylactic vaccine regimens, each compared to a placebo, in preventing HIV acquisition. The trial involved 1,512 randomized participants, with various stages of follow-up and vaccine administration.
Seroconversion rates, potential exposure, and PrEP adherence were analyzed, with Basajja explaining that while the vaccines were safe, they did not reduce HIV infection. The trial results highlighted that more infections occurred in the vaccine groups, but without a clear explanation, cautious interpretation was advised.
Objectives and Design of the Study:
The study aimed to assess the safety and efficacy of two HIV-1 prophylactic vaccine regimens, each compared to a placebo, in preventing HIV acquisition.
- Vaccine A: DNA/AIDSVAX in alum
- Vaccine B: DNA, MVA-CMDR, Gp140 in MPLA-L
- Placebo: Saline
Primary analysis covered visits 9-15 (74 weeks), while secondary analysis covered visits 2-15 (74 weeks). The study also compared the safety and effectiveness of Descovy relative to Truvada in reducing HIV incidence, considering the background incidence. Primary analysis focused on visits 2-9 (26 weeks) for study PrEP, and visits 9-15 (74 weeks) for non-study PrEP.
Vaccine Trial Consort Flow:
- 1,512 participants were randomized.
- 1,504 received at least one vaccine.
- 1,315 received three vaccines.
- 1,311 participants were HIV-negative at visit 9.
- 1,299 were included in the primary analysis.
However:
- 8 participants did not start vaccination as they did not return to the center.
- 57 did not receive the second vaccine.
- 132 did not receive the third vaccine.
- 4 participants were HIV-positive at the start of vaccine follow-up.
- No HIV testing was conducted during vaccine trial follow-up (N=12).
- 1,504 participants were included in the safety analysis set.
Study Schema:
Injections:
- Vaccine Group A: DNA-HIV-PT 123 and AIDSVAX B/E (weeks 0, 4, 24, 48)
- Vaccine Group B: DNA-HIV-PT 123 and CN54gp 140=MPLA-L (weeks 0, 4), followed by MVA-CMDR and CN54gp 140+MPLA-L (weeks 24, 48)
- Vaccine Group C: Saline placebo (weeks 0, 4, 24, 48)
Seroconversions:
- 1,512 participants were randomized.
- 1,509 tested negative at baseline (Visit 2).
- 32 seroconverted during the trial (Secondary vaccine analysis) at a rate of 1.3 per 100 person-years (95% CI: 0.9-1.8).
- 6 seroconversions occurred by visit 9 (3 at V7, 2 at V8, 1 at V9).
- 26 tested positive after Visit 9.
- 3 completed three vaccinations.
- 23 seroconversions were included in the primary vaccine analysis.
- All seroconverted participants were linked to care except one, whom the team is still trying to reach.
The DNA-AIDSVAX primary efficacy analysis showed that out of 1,055 participants, 14 contracted HIV during a follow-up of 1,266.4 person-years, resulting in an incidence rate of 1.11 (95% CI: 0.65-1.87). Among the 523 placebo participants, the incidence was 0.48 (95% CI: 0.15-1.48) over 630.3 person-years.
Key Messages:
- Safety: The trial vaccines were safe.
- Efficacy: The vaccines did not reduce HIV infection.
- Infection Rates: More infections occurred in the vaccine groups, but this should be interpreted cautiously with a clear explanation. The rates were similar to or lower than expected for the regions and populations involved.
- PrEP: Counseling and promotion of PrEP were emphasized at every visit, which may have contributed to the overall low HIV incidence during the trial.
- HIV Transmission: The trial vaccines cannot cause HIV infection as there is no mechanism for them to do so.
Next Steps:
- Share the results with participants, key stakeholders, and communities involved in the trial, informing them about which group they were in.
- Continue follow-up testing, proactively providing it, and promoting PrEP. Facilitate referrals for care if any infections occur.
- Promote continuous HIV prevention strategies.
- Conduct more HIV vaccine clinical trials to find safe and effective vaccines.
Basajja concluded by thanking the funders of the trial, including EDCTP, BMGF, Wellcome Trust, and others.
The journalists applauded the researchers for their efforts to find measures to address the spread of HIV/AIDS, with Malik, on behalf of HEJNU, expressing gratitude to MRC/UVRI for their continued support of science cafés organized by HEJNU in the Masaka region.
End.