The HIV Vaccine Chronicle
An independent continuation of hivpave.org · est. 2005
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The record moves

2026-09-04 · NO. 002 · RECORD UPDATE · 5 MIN READ

The launch notes promised we publish when the record moves, not on a schedule. Eleven days later it has moved twice — both times in Phase 1, both times in the germline-targeting line the closing entry of the chronicle flagged as the field's rebuild. Neither development is an efficacy trial. No efficacy trial is running anywhere. Both matter anyway.

1. Cape Town: BRILLIANT 011 gives itself its first shots

In late January, at the Desmond Tutu HIV Foundation site at Groote Schuur Hospital, the first participant was enrolled in BRILLIANT 011 — the first first-in-human HIV vaccine trial led from Africa to open since the continent's efficacy hopes closed with PrEPVacc. By late February, seven of a planned twenty HIV-negative volunteers had received their first vaccinations.

The trial tests two germline-targeting immunogens — BG505 GT1.1 and 426c.Mod.Core-C4b — with the SMNP adjuvant, the same design family as IAVI G002 and G003. It is the stripped-down survivor of BRILLIANT 001, a five-country, 60-participant version that was to start in February 2025 and died with the U.S. foreign-aid terminations. The consortium — SAMRC, the Wits Health Consortium, Desmond Tutu, and partners across Kenya, Tanzania and Mozambique — rebuilt the protocol around a different adjuvant and new funders, and opened a year later almost to the day.

"An HIV vaccine developed through African science, for African populations, is becoming increasingly possible." SOUTH AFRICAN MEDICAL RESEARCH COUNCIL, JANUARY 2026

Grade B: the SAMRC announcement and trial-site reporting carry the design and enrollment numbers; the registry listing carries the protocol. Primary endpoints are safety and immunogenicity — the precursor-frequency question, not protection. Results are expected in 2027.

2. Zurich and Bern: RENEW-SHCS reads out safety in people with HIV

The same immunogen family crossed a different threshold in August: an interim safety analysis of RENEW-SHCS, the first trial of a germline-targeting HIV vaccine candidate in people already living with HIV on suppressive ART, posted as a preprint on August 24.

Twenty-three participants from the Swiss HIV Cohort Study — split between those whose immune systems had previously produced broadly neutralizing antibody precursors and those who had not — received a single dose of BG505 SOSIP.v4.1-GT1.1. The verdict: no vaccine-related serious adverse events. Local reactions in 96%, systemic in 83%, nearly all grade 1–2 and transient. No participant lost viral suppression. One had two brief viral blips, one before vaccination and one sixteen weeks after, both re-suppressing on their own.

The trial was paused over an adjuvant stability issue — a manufacturing problem, not a safety signal, and the distinction matters. The finding that survives the pause: vaccinating ART-treated people with these immunogens looks like vaccinating anyone else. That opens therapeutic and cure-research uses of the germline-targeting platform, not just preventive ones.

Grade B (preprint, single-arm, open-label, 23 participants). It is not, and does not claim to be, evidence of efficacy.

3. What the ledger says

Read against the trial archive, these are entry number ten's grandchildren: small, deliberate, first-in-something. The last time the field ran an efficacy trial it was stopped for futility in 2024. The next one, if the germline-targeting line holds, is a late-this-decade bet.

And the prevention line did not wait. Lenacapavir's twice-yearly regimen is moving from trial to clinic while the vaccine line rebuilds from first principles. The two lines of this ledger keep their divergence — and we keep recording it.

Sources

RENEW-SHCS interim safety analysis, medRxiv preprint 2026.08.24.26360985 (23 participants, Switzerland, posted 2026-08-24) · SAMRC press release on BRILLIANT 011 first enrollment (2026-01-22) · trial-site reporting from Cape Town (February 2026). Registry numbers will be added to the archive when listings go public.