CompletedPhase 1

A Phase I, Randomized, Double-Blind, Placebo-Controlled Safety, Tolerability and Immunogenicity Study of Candidate HIV-1 Vaccines ChAdOx1.HTI and MVA.HTI With Recombinant HIV-1 Envelope Protein ConM SOSIP.v7 gp140 Vaccine, Adjuvanted With MPLA Liposomes in ART-Suppressed HIV-1 Positive Individuals

Spain30 participantsStarted 2022-03-30

Plain-language summary

BCN03 is a Single-site, randomized, double-blind, placebo-controlled, phase I study to evaluate the safety, tolerability, immunogenicity, and efficacy of a vaccine regimen that includes a sequence of the T- and B-cell immunogens ChAdOx1.HTI and MVA.HTI and ConM SOSIP.v7 gp140 adjuvanted with MPLA liposomes in 30 virologically-suppressed ART-treated HIV-1 positive individuals.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Males and females aged at least 18 years on the day of screening and no greater than 60 years on the day of the first IMP administration.
✓. Confirmed HIV-1 infection.
✓. Optimal virological suppression for at least 2 years prior to the screening visit, defined as maintained pVL \<50 cop/ml allowing for isolated blips (non-consecutive 50-200 copies/mL)
✓. Being on the same ART regimen within at least 4 weeks prior to screening visit.
✓. CD4 count ≥ 500 cells/mm3 at the screening visit.
✓. Nadir CD4 count ≥ 350 cells/mm3. Lower counts at the moment of acute HIV-1 infection will be allowed only if appropriate immune recovery was followed after ART initiation and ART was not initiated within first 6 months after estimated time of HIV-1 acquisition.
✓. Willing and able to be adherent to their ART regimen for the duration of the study.
✓. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.

Exclusion criteria

What they're measuring

Local IMP-related AEs of Grade 3 and 4

Timeframe: From first administration up to week 30 (i.e., start of ATI, 2 weeks after last administration).

Systemic IMP-related AEs of Grade 3 and 4

Timeframe: From first administration up to week 30 (i.e., start of ATI, 2 weeks after last administration).

Descriptive of AEs

Timeframe: From first administration up to week 30 (i.e., start of ATI, 2 weeks after last administration)

Trial details

NCT IDNCT05208125

SponsorIrsiCaixa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-30

View on ClinicalTrials.gov More HIV Infection trials

Plain-language summary

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Males and females aged at least 18 years on the day of screening and no greater than 60 years on the day of the first IMP administration.
✓. Confirmed HIV-1 infection.
✓. Optimal virological suppression for at least 2 years prior to the screening visit, defined as maintained pVL \<50 cop/ml allowing for isolated blips (non-consecutive 50-200 copies/mL)
✓. Being on the same ART regimen within at least 4 weeks prior to screening visit.
✓. CD4 count ≥ 500 cells/mm3 at the screening visit.
✓. Nadir CD4 count ≥ 350 cells/mm3. Lower counts at the moment of acute HIV-1 infection will be allowed only if appropriate immune recovery was followed after ART initiation and ART was not initiated within first 6 months after estimated time of HIV-1 acquisition.
✓. Willing and able to be adherent to their ART regimen for the duration of the study.
✓. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.

Exclusion criteria

What they're measuring

Local IMP-related AEs of Grade 3 and 4

Timeframe: From first administration up to week 30 (i.e., start of ATI, 2 weeks after last administration).

Systemic IMP-related AEs of Grade 3 and 4

Timeframe: From first administration up to week 30 (i.e., start of ATI, 2 weeks after last administration).

Descriptive of AEs

Timeframe: From first administration up to week 30 (i.e., start of ATI, 2 weeks after last administration)