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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

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ClinicalTrials.gov Identifier: NCT03060629
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Brief Summary:
The primary purpose of this study is to assess the preventive vaccine efficacy (VE), safety and tolerability of a heterologous prime/boost regimen utilizing Ad26.Mos4.HIV and aluminum-phosphate adjuvanted Clade C gp140 for the prevention of Human Immuno Virus (HIV) infection in HIV-seronegative women residing in sub-Saharan Africa from confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits.

Condition or disease Intervention/treatment Phase
HIV-1 Biological: Ad26.Mos4.HIV Biological: Clade C gp140 Biological: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Sponsor will be also blinded
Primary Purpose: Prevention
Official 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
Actual Study Start Date : November 3, 2017
Estimated Primary Completion Date : November 2, 2020
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Group 1
Participants will receive Ad26.Mos4.HIV 5*10^10 virus particles (vp) as 0.5 milliliter (mL) via Intramuscular (IM) injection into the left deltoid on Months 0, 3, 6, and 12 and Clade C gp140 (250 [microgram] mcg) mixed with Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12.
Biological: Ad26.Mos4.HIV
Participants will receive Ad26.Mos4.HIV 5x10^10 virus particles (vp) as 0.5 milliliter (mL) via Intramuscular (IM) into the left deltoid on Months 0, 3, 6, and 12.

Biological: Clade C gp140
Participants will receive Clade C gp140 (250 mcg) mixed with Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12.

Placebo Comparator: Group 2
Participants will receive Placebo for Ad26.Mos4.HIV as 0.5 mL into the left deltoid on Months 0, 3, 6, and 12 and Placebo for Clade C gp140 / Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12.
Biological: Placebo
Participants will receive matching placebo.




Primary Outcome Measures :
  1. 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 ]
    VE (7-24) is defined as the cumulative incidence ratio (vaccine/placebo) of the HIV-1 endpoint between Month 7 and Month 24 after enrollment in the Per-Protocol (PP) population.

  2. Percentage of Participants Experiencing Reactogenicity Sign or Symptom [ Time Frame: 3 days after each vaccination ]
    Each participant's reactogenicity will be counted once under the maximum severity for each injection visit.

  3. 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) ]
    Adverse events by body system, severity, and assessed relationship to study products.


Secondary Outcome Measures :
  1. Vaccine Efficacy as Derived From Confirmed HIV1 Infections Diagnosed Between Enrollment and the Month 24 Visit [ Time Frame: From Baseline to 24 Months ]
    VE (0-24) is defined as the cumulative incidence ratio (vaccine/placebo) of the HIV-1 endpoint between Month 0 and Month 24 after enrollment.

  2. Vaccine Efficacy as Derived From Confirmed HIV1 Infections Diagnosed Between Enrollment and the Month 36 Visit [ Time Frame: Baseline up to 36 Months ]
    VE (0-36) is defined as the cumulative incidence ratio (vaccine/placebo) of the HIV-1 endpoint between Month 0 and Month 36 after enrollment.

  3. 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 ]
    VE (12-24) is defined as the cumulative incidence ratio (vaccine/placebo) of the HIV-1 endpoint between Month 12 and Month 24 after enrollment.

  4. Vaccine Efficacy as Derived From Confirmed HIV1 Infections Diagnosed Between the Month 12 and the Month 36 Visits [ Time Frame: From Month 12 to Month 36 ]
    VE (12-36) is defined as the cumulative incidence ratio (vaccine/placebo) of the HIV-1 endpoint between Month 12 and Month 36 after enrollment.

  5. Immunogenicity of the Vaccine Regimen [ Time Frame: Up to Month 24 ]
    Immunogenicity of the vaccine regimen, assessed by Vaccine-specific antibody and T cell responses.

  6. Immunogenicity and Immune Response Biomarkers as Correlates of Risk of Subsequent HIV Acquisition [ Time Frame: Up to Month 24 ]
    Immunogenicity and Immune Response are assessed by BiomarkersVaccine-specific antibody and T cell responses correlated with vaccine efficacy.

  7. Vaccine Efficacy Assessed by Various Baseline and Demographic Characteristics [ Time Frame: Up to Month 24 ]
    The vaccine efficacy assessed by various baseline and demographic characteristics diagnosed by HIV-1 infection.

  8. Genotypic Characteristics of Viral Sequences From HIV-1 Infected Participants at HIV-1 Diagnosis, Such as Signature Site Mutations [ Time Frame: Baseline up to 36 Months ]
    The genotypic characteristics of viral sequences from HIV-1-infected participants at HIV-1 diagnosis assessed by signature site mutations.

  9. 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 36 Months ]
    Viral sequences from HIV-1-infected participants at HIV-1 diagnosis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 other than influenza vaccine 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)
  • Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B)
  • Immunosuppressive medications received within 6 months before first vaccination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060629


Contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
Malawi
UNC Lilongwe Project Not yet recruiting
Lilongwe, Malawi
Mozambique
Polana Caniço Health Research and Training Center (CISPOC) Not yet recruiting
Maputo, Mozambique
South Africa
Josha Research Recruiting
Bloemfontein, South Africa, 9301
Emavundleni Research Centre Not yet recruiting
Cape Town, South Africa, 7750
University of Cape Town IDM/CIDRI Research Site Not yet recruiting
Cape Town, South Africa, 7784
Masiphumelele Research Centre Recruiting
Cape Town, South Africa, 7975
Ndlovu Elandsdoorn Site Recruiting
Dennilton, South Africa, 0485
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital Recruiting
Diepkloof, South Africa, 1862
The Aurum Institute Klerksdorp Clinical Research Centre Not yet recruiting
Klerksdorp, South Africa, 2571
Qhakaza Mbokodo Research Centre Recruiting
Kwazulu-Natal, South Africa, 4030
South African Medical Research Council Chatsworth Clinical Research Site Recruiting
Kwazulu-Natal, South Africa, 4030
Centre for the AIDS Programme of Research in South Africa Not yet recruiting
Kwazulu-Natal, South Africa, 4110
South African Medical Research Council Tongaat Clinical Research Site Not yet recruiting
Kwazulu-Natal, South Africa, 4399
Stanza Clinical Research Centre : Mamelodi Recruiting
Mamelodi East, South Africa, 122
HIV Vaccine Research Unit, Mthatha Not yet recruiting
Mthatha, South Africa, 5099
MeCRU Clinical Research Unit Not yet recruiting
Pretoria, South Africa, 204
The Aurum Institute Rustenburg Clinical Research Site Not yet recruiting
Rustenburg, South Africa, 300
Setshaba Research Centre Not yet recruiting
Soshanguve, South Africa, 152
Perinatal HIV Research Unit (PHRU), Kliptown Not yet recruiting
Soweto, South Africa, 1809
The Aurum Institute: Tembisa Clinical Research Centre Not yet recruiting
Tembisa, South Africa, 1632
Zambia
Zambia Emory HIV Research Project (ZEHRP) Not yet recruiting
Lusaka, Zambia, P/BagE891
Centre for Infectious Disease Research in Zambia (CIDRZ) Not yet recruiting
Matero, Lusaka, Zambia
Zambia Emory HIV Research Project (ZEHRP) Not yet recruiting
Ndola, Zambia
Zimbabwe
St Mary's Clinic Not yet recruiting
Chitungwiza, Zimbabwe
University of Zimbabwe-UCSF Recruiting
Harare - Seke South, Zimbabwe
Sponsors and Collaborators
Janssen Vaccines & Prevention B.V.
Investigators
Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT03060629     History of Changes
Other Study ID Numbers: CR108263
VAC89220HPX2008 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
HVTN 705 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
HVTN 705/VAC89220HPX2008 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Aluminum phosphate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents