NCT02685020

Brief Summary

The primary purpose of this study is to assess safety, tolerability of the different vaccine schedules (different regimen durations and different number of dose administrations) with Ad26.Mos.HIV and Clade C Glycoprotein (gp) 140 and to assess Envelope (Env)-binding Antibody (Ab) responses of the different vaccine schedules.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 28, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2019

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

1.8 years

First QC Date

February 12, 2016

Last Update Submit

January 31, 2025

Conditions

Healthy

Keywords

HealthyHuman Immunodeficiency Virusadenovirus serotype 26Ad26.Mos.HIVVaccinePlaceboGlycoproteinIPCAVD010

Outcome Measures

Primary Outcomes (7)

  • Titer to HIV-Envelope Specific Binding Antibodies Assessed by Env-Ab-binding Assay

    Up to Week 72

  • Breadth of HIV-Envelope Specific Binding Antibodies Assessed by Env-Ab-binding Assay

    Up to Week 72

  • Number of Participants With Local and Systemic Reactogenicity for 8 Days After Each Vaccination

    Participants will be asked to note occurrences of local reactions: pain/tenderness, erythema or swelling/induration at the injection site, and systemic events: fever (temperature measurement), fatigue, headache, nausea, myalgia and chills daily for 8 days post-vaccination. These occurrences will be recorded through the diary card provided to serve as a reminder to the participants for the next clinic visit.

    Up to 8 days after each vaccination

  • Treatment Emergent Adverse Events (AEs)

    Up to Week 72

  • Serious Adverse Events (SAEs) and AEs of Special Interest (AESI)

    Up to Week 124

  • Discontinuations From Vaccination or From Study due to AEs

    At the time of discontinuation from vaccination or from study (Up to Week 72)

  • Number of Participants With AEs or SAEs

    Up to 28 days after each vaccination

Secondary Outcomes (8)

  • Env-Specific Functional Antibodies: Phagocytosis Score

    Up to Week 72

  • Env-Specific Functional Antibodies: Breadths

    Up to Week 72

  • Env-Specific Binding Antibody Isotypes: Titers

    Up to Week 72

  • Env-Specific Binding Antibody Isotypes: Breadths

    Up to Week 72

  • Env-Specific Neutralizing Antibodies (nAbs): Titers

    Up to Week 72

  • +3 more secondary outcomes

Other Outcomes (1)

  • Mucosal Immunogenicity

    Up to week 72

Study Arms (6)

Group 1A

EXPERIMENTAL

Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by Ad26.Mos.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 microgram (mcg) of total protein mixed with adjuvant (aluminum phosphate) at Week 24 and 48.

Biological: Ad26.Mos.HIVBiological: Clade C gp140

Group 1B

PLACEBO COMPARATOR

Participants will receive placebo at weeks 0, 12, 24 and 48.

Drug: Placebo

Group 2A

EXPERIMENTAL

Participants will receive Ad26.Mos.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) at Week 0, 12 and 24.

Biological: Ad26.Mos.HIVBiological: Clade C gp140

Group 2B

PLACEBO COMPARATOR

Participants will receive placebo at weeks 0, 12 and 24.

Drug: Placebo

Group 3A

EXPERIMENTAL

Participants will receive Ad26.Mos.HIV vaccine at Week 0; followed by Ad26.Mos.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) at Week 8 and 24.

Biological: Ad26.Mos.HIVBiological: Clade C gp140

Group 3B

PLACEBO COMPARATOR

Participants will receive placebo at weeks 0, 8 and 24.

Drug: Placebo

Interventions

Ad26.Mos.HIVBIOLOGICAL

Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5\*10\^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.

Group 1AGroup 2AGroup 3A
Clade C gp140BIOLOGICAL

The Clade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly.

Group 1AGroup 2AGroup 3A
PlaceboDRUG

Normal saline, 0.5 mL injection administered intramuscularly.

Group 1BGroup 2BGroup 3B

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is voluntarily willing to participate in the study
  • Participant must be healthy on the basis of physical examination, medical history, electrocardiogram (ECG), and vital signs measurement performed at Screening
  • Participants are negative for Human Immunodeficiency Virus (HIV) infection at Screening
  • All female participants of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin \[beta hCG\]) at the Screening visit, and a negative urine pregnancy test pre-dose on Day 1
  • Participants are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures

You may not qualify if:

  • Participant has chronic hepatitis B or active hepatitis C, active syphilis infection, chlamydia, gonorrhea, or trichomonas . Active syphilis documented by serology unless positive serology is due to past treated infection
  • In the 12 months prior to randomization, participant has a history of newly acquired herpes simplex virus type 2, syphilis, gonorrhea, non-gonococcal urethritis, chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B
  • Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
  • Participant has had major surgery within 4 weeks prior to Screening or planned major surgery through the course of the study
  • Participant has had a thyroidectomy or active thyroid disease requiring medication during the last 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Boston, Massachusetts, United States

Location

Related Publications (1)

  • Stephenson KE, Wegmann F, Tomaka F, Walsh SR, Tan CS, Lavreys L, Ansel JL, Kanjilal DG, Jaegle K, Nkolola JP, Peter L, Fogel R, Bradshaw C, Tyler A, Makoni T, Howe L, Quijada D, Chandrashekar A, Bondzie EA, Borducchi EN, Yanosick KE, Hendriks J, Nijs S, Truyers C, Tolboom J, Zahn RC, Seaman MS, Alter G, Stieh DJ, Pau MG, Schuitemaker H, Barouch DH. Comparison of shortened mosaic HIV-1 vaccine schedules: a randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) and a preclinical study in rhesus monkeys (NHP 17-22). Lancet HIV. 2020 Jun;7(6):e410-e421. doi: 10.1016/S2352-3018(20)30001-1. Epub 2020 Feb 17.

    PMID: 32078815DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Janssen Vaccines & Prevention B.V. Clinical Trial

    Janssen Vaccines & Prevention B.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2016

First Posted

February 18, 2016

Study Start

March 28, 2016

Primary Completion

January 5, 2018

Study Completion

January 3, 2019

Last Updated

February 3, 2025

Record last verified: 2025-01

Locations

US(1)