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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 : Active, not recruiting
First Posted : February 23, 2017
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Tracking Information
First Submitted Date  ICMJE February 17, 2017
First Posted Date  ICMJE February 23, 2017
Last Update Posted Date November 24, 2021
Actual Study Start Date  ICMJE November 3, 2017
Estimated Primary Completion Date July 23, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2017)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2020)
  • 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.
  • 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) ]
    VE (0-57) is defined as the cumulative incidence ratio (vaccine/placebo) of the HIV-1 endpoint between Month 0 and Month 57 (end of study) after enrollment.
  • 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.
  • 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) ]
    VE (12-57) is defined as the cumulative incidence ratio (vaccine/placebo) of the HIV-1 endpoint between Month 12 and Month 57 (end of study) after enrollment.
  • 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.
  • 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.
  • 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.
  • 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 ]
    The genotypic characteristics of viral sequences from HIV-1-infected participants at HIV-1 diagnosis assessed by signature site mutations.
  • 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 ]
    Viral sequences from HIV-1-infected participants at HIV-1 diagnosis.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 gp 140 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Sponsor will be also blinded
Primary Purpose: Prevention
Condition  ICMJE HIV-1
Intervention  ICMJE
  • 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.
  • Biological: Placebo
    Participants will receive matching placebo.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Biological: Ad26.Mos4.HIV
    • Biological: Clade C gp140
  • 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.
    Intervention: Biological: Placebo
Publications * Barouch DH, Tomaka FL, Wegmann F, Stieh DJ, Alter G, Robb ML, Michael NL, Peter L, Nkolola JP, Borducchi EN, Chandrashekar A, Jetton D, Stephenson KE, Li W, Korber B, Tomaras GD, Montefiori DC, Gray G, Frahm N, McElrath MJ, Baden L, Johnson J, Hutter J, Swann E, Karita E, Kibuuka H, Mpendo J, Garrett N, Mngadi K, Chinyenze K, Priddy F, Lazarus E, Laher F, Nitayapan S, Pitisuttithum P, Bart S, Campbell T, Feldman R, Lucksinger G, Borremans C, Callewaert K, Roten R, Sadoff J, Scheppler L, Weijtens M, Feddes-de Boer K, van Manen D, Vreugdenhil J, Zahn R, Lavreys L, Nijs S, Tolboom J, Hendriks J, Euler Z, Pau MG, Schuitemaker H. Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19). Lancet. 2018 Jul 21;392(10143):232-243. doi: 10.1016/S0140-6736(18)31364-3. Epub 2018 Jul 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 4, 2020)
2637
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2017)
2600
Estimated Study Completion Date  ICMJE July 23, 2022
Estimated Primary Completion Date July 23, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malawi,   Mozambique,   South Africa,   Zambia,   Zimbabwe
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03060629
Other Study ID Numbers  ICMJE 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. )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Vaccines & Prevention B.V.
Study Sponsor  ICMJE Janssen Vaccines & Prevention B.V.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
PRS Account Janssen Vaccines & Prevention B.V.
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP