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HIVPhase 1NCT02366013

Trial of the Safety and Immunogenicity of an Oral, Replicating Ad26 Vectored HIV-1 Vaccine

A Phase 1 study testing rcAd26.MOS1.HIV-Env 1x10^8 vp, rcAd26.MOS1.HIV-Env 1x10^9 vp and rcAd26.MOS1.HIV-Env 1x10^10 vp in people with HIV, run by International AIDS Vaccine Initiative at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a dose escalation study to test the safety and immunogenicity of an oral HIV-1 vaccine. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
HIV
What is being tested?
rcAd26.MOS1.HIV-Env 1x10^8 vp, rcAd26.MOS1.HIV-Env 1x10^9 vp and rcAd26.MOS1.HIV-Env 1x10^10 vp
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
Jan 2015to Jun 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 18-40 years old.
  • Ability and willingness to provide informed consent.
  • Complete an assessment of understanding
  • Available for the duration of the trial, including willingness to be kept in an isolation facility
  • From Day 10 through 4 months following vaccination must reside alone or with no more than 2 adults (age 18-60) and no minors under age 18
  • Good general health as shown by medical history, physical exam, and screening
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  • Willing to undergo HIV testing and willing to receive risk reduction counseling
  • All female volunteers must be willing to undergo urine pregnancy tests
  • Sexually active males must be willing to use an effective method of contraception until at least 4 months after vaccination
  • Women of child bearing potential commit to use an effective method of contraception when sexually active with males for 4 months after vaccination
  • Willing to forgo donations of blood or any other tissues during the study and, for those who test HIV positive due to trial vaccination (vaccine-induced HIV seroreactivity), until the anti-HIV antibody titers become undetectable
  • Low risk for HIV infection and willing to maintain low-risk behavior for the trial duration

Who cannot join

  • Confirmed HIV-1 or HIV-2 infection; confirmed HCV, HBV, or syphilis infection
  • Current or planned participation in another clinical trial of an experimental agent during the study period
  • Pregnant or lactating
  • Significant acute or chronic disease, including inflammatory bowel disease or other chronic gastrointestinal disease, immunodeficiency syndrome, or condition requiring immunosuppressant medications
  • Use of anticancer, antituberculosis or other medications considered significant by the investigator within the previous 6 months
  • Receipt of live-attenuated vaccine within the previous 60 days or planned receipt within 60 days after vaccination with Investigational Product (within 14 days for live attenuated influenza vaccine [LAIV]); or receipt of other vaccine (e.g., influenza, pneumococcal), allergy treatment with antigen injections or tuberculin skin test within the previous 14 days or planned receipt within 14 days after vaccination with Investigational Product
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  • Receipt of blood transfusion or blood-derived products within the previous 3 months
  • Receipt of HIV vaccine(s) in a prior HIV vaccine trial.
  • Previous severe local or systemic reactions to vaccination
  • History of splenectomy
  • History of seizure in the last 3 years
  • Known autoimmune disease
  • Asthma other than mild, well-controlled asthma.
  • Diabetes mellitus type 1 or type 2
  • Thyroidectomy, or thyroid disease requiring medication during the last 12 months
  • Angioedema within the last 3 years if episodes are considered serious or have required medication within the last 2 years
  • Hypertension
  • Body mass index (BMI) ≥ 40
  • Bleeding disorder diagnosed by a doctor
  • Malignancy (Not excluded: a volunteer with a surgical excision and subsequent observation period that in the investigator's estimation has a reasonable assurance of sustained cure or is unlikely to recur during the study period)
  • Psychiatric condition that compromises safety of the volunteer or precludes compliance with the protocol
  • All healthcare workers with direct patient contact
  • Childcare worker who has direct contact with children
  • Individuals employed as food handlers or otherwise engaged in the preparation or delivery of food outside of their place of residence
  • Positive urine toxicology test
  • Household contacts 18-60 years of age are also evaluated for eligibility with a more abbreviated list of inclusion/exclusion criteria.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Rochester

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: A Phase 1 Clinical Trial of the Safety and Immunogenicity of an Oral, Replicating Adenovirus 26 Vector Vaccine for HIV-1 (rcAd26.MOS1.HIV-Env) in Healthy HIV-1-uninfected Adults

This is a dose escalation study to test the safety and immunogenicity of an oral HIV-1 vaccine.

Read the detailed description

This study is a phase I dose-escalation randomized, double blind, placebo-controlled study designed to evaluate the safety and immunogenicity of rcAd26.MOS1.HIV-Env, an oral replicating adenovirus 26 vector vaccine in healthy HIV-1 uninfected adults. The vaccine will be administered orally at a single time point (Day 0) at one of four dose levels depending on study group: 1 x 10^8 virus particles (vp), 1 x 10^9 vp, 1 x 10^10 vp and 1 x 10^11 vp. Volunteers will be randomized to vaccine: placebo in a 5:1 ratio in each group.

Volunteers will be screened up to 56 days before vaccination and will be followed for 12 months after vaccination.

Because the vaccine is replication competent, volunteers will be housed in an isolation unit from day -2 through day 9. Household contacts will also be enrolled and tested for possible transmission.

Conditions
HIV
Being tested
rcAd26.MOS1.HIV-Env 1x10^8 vp, rcAd26.MOS1.HIV-Env 1x10^9 vp, rcAd26.MOS1.HIV-Env 1x10^10 vp, rcAd26.MOS1.HIV-Env 1x10^11 vp
Keywords
HIV, HIV Prevention, HIV Vaccine, Healthy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rcAd26.MOS1.HIV-Env 1x10^8 vpBiological

    1 oral capsule, 1x10^8 vp/capsule or 1 placebo capsule; 5:1 vaccine:placebo

  • rcAd26.MOS1.HIV-Env 1x10^9 vpBiological

    10 oral capsules, 1x10^8 vp/capsule or 10 placebo capsules; 5:1 vaccine:placebo

  • rcAd26.MOS1.HIV-Env 1x10^10 vpBiological

    1 oral capsule, 1x10^10 vp/capsule or 1 placebo capsule; 5:1 vaccine:placebo

  • rcAd26.MOS1.HIV-Env 1x10^11 vpBiological

    10 oral capsules, 1x10^10 vp/capsule or 10 placebo capsules; 5:1 vaccine:placebo

Study groups in NCT02366013
Study groupRoleWhat they receive
Group 1Experimental1 dose of rcAd26.MOS1.HIV-Env 1x10^8 vp or placebo
Receives: Biological: rcAd26.MOS1.HIV-Env 1x10^8 vp
Group 2Experimental1 dose of rcAd26.MOS1.HIV-Env 1x10^9 vp or placebo
Receives: Biological: rcAd26.MOS1.HIV-Env 1x10^9 vp
Group 3Experimental1 dose of rcAd26.MOS1.HIV-Env 1x10^10 vp or placebo
Receives: Biological: rcAd26.MOS1.HIV-Env 1x10^10 vp
Group 4Experimental1 dose of rcAd26.MOS1.HIV-Env 1x10^11 vp or placebo
Receives: Biological: rcAd26.MOS1.HIV-Env 1x10^11 vp

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability as measured by number of volunteers reporting the following:

    • Any adverse events within 4 months following vaccination (SAEs within 12 months following vaccination)
    • Moderate or greater unsolicited adverse events related to study product (i.e., suspected adverse reactions) within 4 weeks post-vaccination
    • Moderate or greater solicited reactions within 9 days post-vaccination

    Measured: 4 Months post-vaccination

Secondary outcomes (2)

  1. Proportion (95%CI) of volunteers per dose group with positive shedding responses and mean response per group with 95% CI.

    • Rectal/oral shedding: real-time PCR for rcAd26.MOS1.HIV-Env at 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 17, 21, 7, 12, 21, and 28 days after vaccination.

    Measured: 28 days

  2. Proportion of volunteers per dose group with positive immunological responses and mean response (e.g. GMT) per group with 95% CI.

    • Cellular immunogenicity: Env-specific ELISPOT responses at 4 weeks after vaccination.
    • Humoral immunogenicity: Env-specific binding antibody titers at 4 weeks after vaccination.
    • Durability of responses: immunogenicity assays at 4, 8 and 12 months after vaccination.

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02366013
Sponsor's protocol ID
rcAd001/IAVI R001
Status last verified
Nov 2016
First submitted
4 Feb 2015
Last updated
21 Nov 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Stephenson KE, Keefer MC, Bunce CA, Frances D, Abbink P, Maxfield LF, Neubauer GH, Nkolola J, Peter L, Lane C, Park H, Verlinde C, Lombardo A, Yallop C, Havenga M, Fast P, Treanor J, Barouch DH. First-in-human randomized controlled trial of an oral, replicating adenovirus 26 vector vaccine for HIV-1. PLoS One. 2018 Nov 14;13(11):e0205139. doi: 10.1371/journal.pone.0205139. eCollection 2018.

    PubMed 30427829

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing rcAd26.MOS1.HIV-Env 1x10^8 vp, rcAd26.MOS1.HIV-Env 1x10^9 vp and rcAd26.MOS1.HIV-Env 1x10^10 vp in people with HIV, run by International AIDS Vaccine Initiative at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability as measured by number of volunteers reporting the following: (time frame: 4 Months post-vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02366013, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2016.

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