A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa

• Register: ClinicalTrials.gov
• Last refreshed on: 25 April 2022
• Main ID: NCT03060629
• Date of registration: 17/02/2017
• Prospective Registration: Yes
• Primary sponsor: Janssen Vaccines & Prevention B.V.
• Public title: A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa
• Scientific title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2b Efficacy Study of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-adjuvanted Clade C gp140 in Preventing HIV-1 Infection in Adult Women in Sub-Saharan Africa
• Date of first enrolment: November 3, 2017
• Target sample size: 2637
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03060629
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Malawi, Mozambique, South Africa, Zambia, Zimbabwe

Contacts

• Name: Janssen Vaccines & Prevention B.V. Clinical Trial
• Affiliation: Janssen Vaccines & Prevention B.V.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Sexually active, defined as having had sexual intercourse with a male partner at least
twice in the past 30 days prior to screening, and is considered by the site staff to
be at risk for Human Immunodeficiency Virus (HIV) infection

- Access to a participating HIV Vaccine Trials Network (HVTN) Clinical Research Sites
(CRS) and willingness to be followed for the planned duration of the study

- Willingness to discuss HIV infection risks and willing to receive HIV risk reduction
counseling and appropriate referrals to minimize HIV acquisition, as applicable

- Negative beta human chorionic gonadotropin (beta-HCG) pregnancy test performed prior
to vaccination on the day of initial vaccination. Persons who are NOT of reproductive
potential due to having undergone total hysterectomy or bilateral oophorectomy
(verified by medical records), are not required to undergo pregnancy testing

- Participants must also agree not to seek pregnancy through alternative methods, such
as artificial insemination or in vitro fertilization until 3 months after the last
vaccination

Exclusion Criteria:

- Investigational research agents received within 30 days before first vaccination

- HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received
control/placebo in an HIV vaccine trial, the HVTN 705/HPX2008 (Protocol Safety Review
Team) PSRT will determine eligibility on a case-by-case basis

- Live attenuated vaccines received within 30 days before first vaccination or scheduled
within 14 days after injection (example: measles, mumps, and rubella [MMR]; oral polio
vaccine [OPV]; varicella; yellow fever)

- Any vaccines that are not live attenuated vaccines and were received within 14 days
prior to first vaccination (example, tetanus, pneumococcal, Hepatitis A or B)

- Immunosuppressive medications received within 6 months before first vaccination



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Female

Health Condition(s) or Problem(s) studied

HIV-1

Intervention(s)

Biological: Placebo

Biological: Clade C gp140

Biological: Ad26.Mos4.HIV

Primary Outcome(s)

Percentage of Participants Experiencing Reactogenicity Sign or Symptom [Time Frame: 3 days after each vaccination]

Percentage of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [Time Frame: 30 Days after each vaccination (Approximately up to 42 Months)]

Vaccine Efficacy (VE) as Derived From Confirmed HIV-1 Infections Diagnosed Between the Month 7 and Month 24 Visits [Time Frame: From Month 7 to Month 24]

Secondary Outcome(s)

Immunogenicity and Immune Response Biomarkers as Correlates of Risk of Subsequent HIV Acquisition [Time Frame: Up to Month 24]

Vaccine Efficacy as Derived From Confirmed HIV1 Infections Diagnosed Between the Month 12 and end of Study Visit [Time Frame: From Month 12 to Month 57 (End of study)]

Vaccine Efficacy as Derived From Confirmed HIV1 Infections Diagnosed Between the Month 12 and the Month 24 Visits [Time Frame: From Month 12 to Month 24]

Immunogenicity of the Vaccine Regimen [Time Frame: Up to Month 24]

Comparison of Genomic Sequences of Viral Isolates From HIV-1 Infected Vaccine and Placebo Recipients and Assessment by Sieve Analysis Methods of Whether There is Evidence of Vaccine-Induced Immune Pressure on the Viral Sequences [Time Frame: Baseline up to Month 57]

Genotypic Characteristics of Viral Sequences From HIV-1 Infected Participants at HIV-1 Diagnosis, Such as Signature Site Mutations [Time Frame: From Month 12 to Month 24]

Vaccine Efficacy as Derived From Confirmed HIV1 Infections Diagnosed Between Enrollment and the end of Study Visit [Time Frame: Baseline up to Month 57 (End of study)]

Vaccine Efficacy Assessed by Various Baseline and Demographic Characteristics [Time Frame: Up to Month 24]

Vaccine Efficacy as Derived From Confirmed HIV1 Infections Diagnosed Between Enrollment and the Month 24 Visit [Time Frame: From Baseline to 24 Months]

Secondary ID(s)

HVTN 705

HVTN 705/VAC89220HPX2008

CR108263

VAC89220HPX2008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors