BCG Vaccination Effect on Latent Reservoir Size in Treated HIV-1 Infection:

NCT05004038 | Completed Phase 2

• 1 other identifier: 2021-01481
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A phase IIA randomized double-blind placebo-controlled single-centre study of the effect of Bacillus Calmette-Guérin (BCG) vaccination on the HIV latent reservoir

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• Change in size of the HIV-1 latent reservoir at 6 months

  The primary outcome will be the change in size of the HIV-1 latent reservoir at 6 months post-BCG vaccination compared to pre-vaccination in all patients, with each patient serving as their own control. This HIV-1 latent reservoir size will be measured as total HIV-1 DNA in peripheral blood mononuclear cells, a well-established and extensively validated marker for the HIV-1 reservoir found to be sensitive, clinically relevant and feasible in larger populations.

  6 months for each patient

Secondary Outcomes (3)

• The change in size of the HIV-1 latent reservoir at 3 months

  3 months for each patient

• The change in size of the HIV-1 latent reservoir at 3 months (in all patients) and 9 months (in the early group) post-BCG vaccination compared to pre-vaccination

  9 months for each patient

• The frequency and incidence of adverse events of interest in the verum group compared to the placebo group

  9 months

Study Arms (2)

Early Group

ACTIVE COMPARATOR

We will conduct a randomized, double-blind trial using a stepped-wedge design and involving a total of 60 patients with stable treated HIV and suppressed viral load who will all receive the BCG vaccine during the course of the study. Patients will be divided into two groups of equal size (early and late groups regarding administration of the BCG verum). The trial will be placebo-controlled and double-blind. Patients in the early group will receive the BCG verum at the beginning of Treatment Phase 1, and then the placebo at the beginning of Treatment Phase 2.

Biological: BCG Vaccine AJVaccines

Late Group

ACTIVE COMPARATOR

Patients in the late group will receive placebo at the beginning of Treatment Phase 1 and then the BCG verum at the beginning of Treatment Phase 2.

Biological: BCG Vaccine AJVaccines

Interventions

BCG Vaccine AJVaccines BIOLOGICAL

Single intradermal injection of BCG Vaccine according to published Summary of Product Characteristics

Early Group; Late Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent as documented by signature (see Informed Consent Form),
• Age ≥18 years,
• HIV-1 infection under continuous antiretroviral therapy for ≥1.5 years as requested in the Systems X Cohort,
• Current participation in the Swiss HIV Cohort Study and past participation in the Systems X Cohort.

You may not qualify if:

• History of virological failure or treatment interruption at any time, defined as HIV-1 viral load \>200c/ml at two consecutive measurements at least 4 weeks apart,
• CD4 T-cell count \<200/μl at any time or \<350/μl during the past 1 year
• Presence of other relevant immunosuppression according to the investigator in addition to HIV (a daily steroid intake of ≥20mg is considered clinically relevant),
• History of or current clinical evidence of active tuberculosis,
• Previous positive tuberculin skin test or tuberculosis INF-gamma release assay (Quantiferon-Test) within the past 10 years,
• Previous BCG-vaccination within the past 10 years,
• Known allergy to BCG vaccine or any of its components,
• Documented current febrile illness at screening or in the past 7 days.
• Women who are pregnant or breast-feeding

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• West E, Chaudron SE, Russenberger D, Grube C, Metzner KJ, Neumann K, Tschumi J, Kalin M, Tutumlu TK, Dolle C, Kouyos RD, Gunthard HF, Braun DL, Nemeth J. Safety of Bacillus Calmette-Guerin Vaccination and Impact on HIV-1 Latent Reservoir Size in People With Treated HIV-1 Infection. Open Forum Infect Dis. 2025 Sep 29;12(10):ofaf611. doi: 10.1093/ofid/ofaf611. eCollection 2025 Oct.

  PMID: 41127455 RESULT

Study Officials

• Johannes Nemeth, Dr. med.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A phase IIA randomized double-blind placebo-controlled single-centre study

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 13, 2021
• Study Start: January 4, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)