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Acquired Immunodeficiency SyndromePhase 1NCT02762045

Clinical Trial of Recombinant Adenovirus Type 5 AIDS Vaccine

A Phase 1 study testing Ad5-gag in people with Acquired Immunodeficiency Syndrome, run by Centers for Disease Control and Prevention, China at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a randomized, double-blind placebo-controlled dose-escalation clinical trial to evaluate the safety and the immunogenicity of Adenoviral vector 5 HIV-1 vaccines in subjects receiving stable highly active antiretroviral therapy(HAART) . Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Acquired Immunodeficiency Syndrome
What is being tested?
Ad5-gag
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteChina
Study dates
Apr 2016to Dec 2017
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Are willing to participate this study and available for follow-up for the duration of the study.
  • Men and women aged 18-50 years.
  • Are HIV-positive.
  • Have been taking stable anti-HIV drugs for at least 6 months.
  • CD4 count ≥ 350 cells/mm3
  • Plasma viral load < 50 copies/ml.
  • Willing to use acceptable forms of contraception at least 21 days prior to first vaccination until 56 days after the last vaccination.

Who cannot join

  • Pregnancy or breast-feeding.
  • History of previous vaccination with an HIV-1 vaccine.
  • Use of immunoinhibitory agents, such as corticosteroids or cytotoxic drugs by oral administration, injection route or inhalation route within 6 months of study entry (But corticosteroids used for allergic rhinitis and skin topical application of corticosteroids were not included); Use of immunomodulatory agents including but not limited to interleukin-2(IL-2） and granulocyte-macrophage colony-stimulating factor (GM-CSF) within 30 days of study entry.
  • Use of blood products within 3 months of study entry.
  • Use of other experimental drugs within 3 months of study entry.
  • Any immunization within 3 months of study entry.
Show all 12Show fewer
  • Comply with any of the following items： Active pulmonary tuberculosis； History of serious adverse reaction to other vaccines； Serious asthma； Have untreated thyroid disease; Syphilis
  • Laboratory values（Comply with any of the following items）:
  • Hemoglobin < 100 g/L (male subjects)，<90 g/L (female subjects)； Absolute neutrophil count ≤ 1000 cells/mm3； Serum creatinine ≥15 mg/L，endogenous creatinine clearance rate <50 ml/min； alanine aminotransferase（ALT）, aspartate aminotransferase(AST) ≥3× upper limit of normal range； Total bilirubin ≥2× upper limit of normal range
  • Clinically significant electrocardiogram changes.
  • Hypertension ( If it is well controlled by medication and is less than 150/100mmHg , should not be excluded) and other cardiac disease；
  • Any medical, psychiatric, social condition, occupational reason judged by the investigator that would limit the evaluation of a subject.

Trial locations and contacts

1 site in 1 country.

Rongmeng Jiang, M.D. contact

0086-13911900791

13911900791@163.com

China1 site, 1 recruiting

  • Beijing Ditan Hospital of Capital Medical University

    Beijing

    Rongmeng Jiang, M.D., 0086-13911900791, 13911900791@163.com

    Rongmeng Jiang, M.D

    Recruiting

Other trials in China

About this study

Official title: Phase I Clinical Trial of Recombinant Adenovirus Type 5 Therapeutic AIDS Vaccine Expressing Gag

This is a randomized, double-blind placebo-controlled dose-escalation clinical trial to evaluate the safety and the immunogenicity of Adenoviral vector 5 HIV-1 vaccines in subjects receiving stable highly active antiretroviral therapy(HAART) .

Read the detailed description

Patients continue antiretroviral medications throughout the course of this study. Three groups of patients receive dose-escalation (2×10^9VP, 2×10^10VP or 2×10^11VP) injections of Adenovirus vector vaccine (Ad5-gag). Two weeks post immunization of lower dose, if the vaccine is safe and well tolerant, the next dose of immunization will begin. patients are monitored for safety 72 hours after each immunization. In addition, each patient records adverse events in a diary. Patients have regular physical exams, pregnancy tests, and blood drawn for virologic and immunologic assessments. The induction of HIV-specific responses will be measured.

Being tested
Ad5-gag, Placebo
Keywords
Therapeutic Vaccine HIV Adenovirus type 5 vector
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

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

  • Ad5-gagBiological

    Ad5-gag is used as vaccine in all arms.

  • PlaceboBiological

    Also called Preservation Solution

    Preservation Solution is used as control in all arms.

Study groups in NCT02762045
Study groupRoleWhat they receive
Low dose Ad5-gag or PlaceboExperimental1ml low dose Ad5-gag(2x10^9VP) or Preservation solution at weeks 0 and weeks 4.
Receives: Biological: Ad5-gag; Biological: Placebo
Medium dose Ad5-gag or PlaceboExperimental1ml medium dose Ad5-gag(2x10^10VP) or Preservation solution at weeks 0 and weeks 4.
Receives: Biological: Ad5-gag; Biological: Placebo
High dose Ad5-gag or PlaceboExperimental1ml high dose Ad5-gag(2x10^11VP) or Preservation solution at weeks 0 and weeks 4.
Receives: Biological: Ad5-gag; Biological: Placebo

What is being measured

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

  1. Occurrence, intensity and relationship to vaccination of local and systemic adverse events

    To evaluate the safety and tolerance of a replication defective adenovirus expressing HIV-1 gag in HIV-1 infected subjects on highly active antiretroviral therapy.

    Measured: 12 months

Secondary outcomes (1)

  1. Immunogenicity of vaccine

    To evaluate immune responses pre- and post-immunization and between the vaccine and placebo groups.

    Measured: 24 month

Timeline

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

  1. First posted4 May 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2017 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02762045
Sponsor's protocol ID
CDCPChina
Status last verified
May 2016
First submitted
2 May 2016
Last updated
4 May 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ad5-gag in people with Acquired Immunodeficiency Syndrome, run by Centers for Disease Control and Prevention, China at 1 site in China.

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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 4 May 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 China. 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?

Results are not available in the source record.

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

Contact Rongmeng Jiang, M.D. (0086-13911900791, 13911900791@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence, intensity and relationship to vaccination of local and systemic adverse events (time frame: 12 months). 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 NCT02762045.

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 4 May 2016.

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