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Safety, Tolerability and Immunogenicity Study of Different Vaccine Schedules With Ad26.Mos.HIV and Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults

Primary Purpose

Healthy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Ad26.Mos.HIV

Clade C gp140

Placebo

About this trial

This is an interventional prevention trial for Healthy focused on measuring Healthy, Human Immunodeficiency Virus, adenovirus serotype 26, Ad26.Mos.HIV, Vaccine, Placebo, Glycoprotein, IPCAVD010

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Group 1A

Group 1B

Group 2A

Group 2B

Group 3A

Group 3B

Arm Description

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.

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

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.

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

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.

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

Outcomes

Primary Outcome Measures

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

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

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.

Treatment Emergent Adverse Events (AEs)

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

Discontinuations From Vaccination or From Study due to AEs

Number of Participants With AEs or SAEs

Secondary Outcome Measures

Env-Specific Functional Antibodies: Phagocytosis Score

Env-Specific Functional Antibodies: Breadths

Env-Specific Binding Antibody Isotypes: Titers

The Isotyping (Clade C) (IgA, IgG1-4)- Env binding antibody titers will be assessed using ELISA.

Env-Specific Binding Antibody Isotypes: Breadths

The Isotyping (Clade C) (IgA, IgG1-4)- Env binding antibody breadths will be assessed using ELISA.

Env-Specific Neutralizing Antibodies (nAbs): Titers

Env-Specific Neutralizing Antibodies (nAbs): Breadths

Induction of New T-cell Immune Response by the Vaccine

Induction of new T-cell immune response against one or more of the vaccine epitopes using Interferon gamma Enzyme Linked Immuno spot assay (IFNg-ELISPOT assay) measuring Spot forming Units per 1 million peripheral blood mononuclear cells (SFU/1 mio PBMCs) above threshold (> 50 sfu/mio PBMC).

Change From Baseline of the Frequency of HIV-Specific PBMC and/or CD4 and/or CD8 T cells as Measured by ELISpot Interferon (IFN) Gamma

Full Information

NCT ID

NCT02685020

First Posted

February 12, 2016

Last Updated

January 22, 2019

Sponsor

Janssen Vaccines & Prevention B.V.

1. Study Identification

Unique Protocol Identification Number

NCT02685020

Brief Title

Safety, Tolerability and Immunogenicity Study of Different Vaccine Schedules With Ad26.Mos.HIV and Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults

Official Title

A Randomized, Parallel-group, Placebo-controlled, Double-blind Phase 1 Study in Healthy HIV-uninfected Adults to Evaluate Safety/Tolerability and Immunogenicity of Different Vaccine Schedules With Ad26.Mos.HIV and Clade C gp140

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

March 28, 2016 (Actual)

Primary Completion Date

January 5, 2018 (Actual)

Study Completion Date

January 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Vaccines & Prevention B.V.

4. Oversight

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This is a phase 1 single-center, randomized (the study drug is assigned by chance), parallel group (each group of participants will be treated at the same time), placebo-controlled (study in which the experimental treatment or procedure is compared to a pretend treatment with no drug in it to test if the drug has a real effect), and double-blind (neither physician nor participant knows the treatment that the participant receives) study. Participants will be randomized in to 3 groups and will receive study vaccines or placebo. Group 1 will have 4 vaccination time points during 48 weeks, Groups 2 and 3 will have 3 vaccination time points during 24 weeks. The study comprises a Screening Period (up to 4 weeks), a Vaccination Period (maximum 48 weeks), and a Follow-up Period (up to 72 weeks). Participants' safety will be monitored throughout the study. An optional Long-term Extension (LTE) phase (approximately 1 year after Week 72) will be performed for participants randomized to receive study vaccine, who have received all planned vaccinations and are negative for HIV infection at Week 72. The duration of the participation will be approximately 124 weeks for participants participating to the optional LTE phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

Keywords

Healthy, Human Immunodeficiency Virus, adenovirus serotype 26, Ad26.Mos.HIV, Vaccine, Placebo, Glycoprotein, IPCAVD010

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1A

Arm Type

Experimental

Arm Description

Arm Title

Group 1B

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Group 2A

Arm Type

Experimental

Arm Description

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.

Arm Title

Group 2B

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Group 3A

Arm Type

Experimental

Arm Description

Arm Title

Group 3B

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Ad26.Mos.HIV

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Clade C gp140

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Normal saline, 0.5 mL injection administered intramuscularly.

Primary Outcome Measure Information:

Title

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

Time Frame

Up to Week 72

Title

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

Time Frame

Up to Week 72

Title

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

Description

Time Frame

Up to 8 days after each vaccination

Title

Treatment Emergent Adverse Events (AEs)

Time Frame

Up to Week 72

Title

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

Time Frame

Up to Week 124

Title

Discontinuations From Vaccination or From Study due to AEs

Time Frame

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

Title

Number of Participants With AEs or SAEs

Time Frame

Up to 28 days after each vaccination

Secondary Outcome Measure Information:

Title

Env-Specific Functional Antibodies: Phagocytosis Score

Time Frame

Up to Week 72

Title

Env-Specific Functional Antibodies: Breadths

Time Frame

Up to Week 72

Title

Env-Specific Binding Antibody Isotypes: Titers

Description

The Isotyping (Clade C) (IgA, IgG1-4)- Env binding antibody titers will be assessed using ELISA.

Time Frame

Up to Week 72

Title

Env-Specific Binding Antibody Isotypes: Breadths

Description

The Isotyping (Clade C) (IgA, IgG1-4)- Env binding antibody breadths will be assessed using ELISA.

Time Frame

Up to Week 72

Title

Env-Specific Neutralizing Antibodies (nAbs): Titers

Time Frame

Up to Week 72

Title

Env-Specific Neutralizing Antibodies (nAbs): Breadths

Time Frame

Up to Week 72

Title

Induction of New T-cell Immune Response by the Vaccine

Description

Time Frame

Up to Week 72

Title

Change From Baseline of the Frequency of HIV-Specific PBMC and/or CD4 and/or CD8 T cells as Measured by ELISpot Interferon (IFN) Gamma

Time Frame

Up to Week 72

Other Pre-specified Outcome Measures:

Title

Mucosal Immunogenicity

Description

Immune Responses to the Different Vaccine Schedules in Mucosal Secretions.

Time Frame

Up to week 72

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Vaccines & Prevention B.V. Clinical Trial

Organizational Affiliation

Janssen Vaccines & Prevention B.V.

Official's Role

Study Director

Facility Information:

City

Boston

State/Province

Massachusetts

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32078815

Citation

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. Erratum In: Lancet HIV. 2020 Feb 28;:

Results Reference

derived

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Safety, Tolerability and Immunogenicity Study of Different Vaccine Schedules With Ad26.Mos.HIV and Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults

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