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AIDSPhase 2NCT01705223

Safety and Immunogenicity Study of AIDS Vaccine (Combined Use of DNA Vaccine and Recombinant Vaccinia Virus Tiantan)

A Phase 2 study testing DNA vaccine, DNA vaccine prime with the addition of electroporation and rTV boost in people with AIDS, run by National Center for AIDS/STD Control and Prevention, China CDC at 1 site in China.

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 trial studies the safety and immunogenicity of a HIV clade B'/C DNA vaccine followed by recombinant vaccinia virus rTV boost in HIV-uninfected healthy volunteers at low or high risk of HIV infection. In addition, the effect of different intervals of the prime-boost will be studied. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
AIDS
What is being tested?
DNA vaccine, DNA vaccine prime with the addition of electroporation and rTV boost
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
Aug 2012to Jan 2015
Phase
Phase 2
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Willing to be followed for the planned duration of the study, and receive intravenous blood collection and sample storage in the 16~20 months after first vaccination;
  • Understand and agree with the content of informed consent;
  • Volunteers at low risk of HIV infection, or high-risk men who have sex with men (MSM）, who had have oral sex or anal sex with another man in the past 6 months ;
  • Willing to be tested for HIV and syphilis;
  • Before 2 weeks of the first vaccination and after 12 months of the last vaccination, willing to use an effective method of contraception with sexual partner. Female subjects are willing to undergo urine pregnancy test before each vaccination and at the follow-up visit.

Who cannot join

  • Have close contact with people who are pregnant or lactating in the one month after vaccination of rTV vaccine;
  • Have listed diseases or medical history:
  • Have innate or acquired immune deficiency disease or have close contact with patients suffering from the above-mentioned diseases within 1 month of rTV vaccination;
  • Need treatment affecting immunization, e.g. use corticosteroids for more than 2 weeks or use immunosuppressives, e.g. alkylating, anti-metabolite or radiotherapy, etc.; or have close contact with patients suffering from the above-mentioned diseases within 1 month of rTV vaccination;
  • Suffering from immunosuppressive diseases such as cancer, organ or stem cell transplants, non-agammaglobulinemia, etc.; or have close contact with patients suffering from the above-mentioned diseases within 1 month of rTV vaccination;
  • Past or current suffering from eczema or atopic dermatitis; currently suffering from diseases that cause skin damage such as: burns, scald, chicken pox, impetigo, shingles, psoriasis, etc.; or have close contact with patients suffering from the above-mentioned diseases within 1 month of rTV vaccination;
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  • Past or current high blood pressure, heart disease, diabetes, thyroid disease, asthma, angioedema, asplenia syndrome, mental illness, epilepsy, severe anemia, leukopenia and thrombocytopenia, etc.;
  • History of syncope after vaccination or allergies;
  • Currently suffering from acute infectious diseases and febrile diseases；
  • The following circumstances are:
  • Live attenuated vaccine received within 2 months or other vaccine within 2 weeks prior to enrollment;
  • Immunoglobin or blood products received within 4 months prior to enrollment;
  • Participation in another trial of a medicinal product, completed less than 30 days prior to enrollment;
  • Drug abuse, alcoholism, heavy smokers；
  • The following laboratory test abnormalities, except for the results that are assessed by researchers as being no clinical significance：
  • HIV diagnostic assay positive or suspicious, HIV RNA diagnostic assay positive;
  • Anti-DNA antibody or anti-nuclear antibody positive;
  • Other laboratory test abnormalities;
  • Not complying with study protocol or not obtaining informed consent because of medical, spiritual, social, occupational, and/or other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Youan Hospital,Capital Medical University

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: Phase IIa Study of AIDS Vaccine (Combined Use of DNA Vaccine and Recombinant Vaccinia Virus Tiantan)

This trial studies the safety and immunogenicity of a HIV clade B'/C DNA vaccine followed by recombinant vaccinia virus rTV boost in HIV-uninfected healthy volunteers at low or high risk of HIV infection. In addition, the effect of different intervals of the prime-boost will be studied.

Conditions
AIDS
Being tested
DNA vaccine, DNA vaccine prime with the addition of electroporation, rTV boost
Keywords
prophylactic, vaccine
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.

  • DNA vaccineBiological

    4mg/dose, three doses at week 0,4,8

  • DNA vaccine prime with the addition of electroporationBiological

    4mg/dose, three doses at week 0,4,8

  • rTV boostBiological

    at week 16

  • rTV boostBiological

    at week 24

  • rTV boostBiological

    at week 32

Study groups in NCT01705223
Study groupRoleWhat they receive
group AExperimentalDNA vaccine prime at week 0,4,8 and rTV boost at week 16
Receives: Biological: DNA vaccine; Biological: rTV boost
group BExperimentalDNA vaccine prime at week 0,4,8 and rTV boost at week 24
Receives: Biological: DNA vaccine; Biological: rTV boost
group CExperimentalDNA vaccine prime at week 0,4,8 and rTV boost at week 32
Receives: Biological: DNA vaccine; Biological: rTV boost
group DExperimentalDNA vaccine prime with the addition of electroporation at week 0, 4, 8 and rTV boost at week 24
Receives: Biological: DNA vaccine prime with the addition of electroporation; Biological: rTV boost

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 general adverse events

    Measured: 14-day follow-up after DNA vaccine vaccination

  2. Occurrence and relationship to vaccination of any serious AEs (SAEs)

    Measured: During the study period (Month 0-20)

  3. Occurrence, intensity and relationship to vaccination of clinically significant abnormal haematology and biochemistry values (grade 4)

    Measured: During the study period (Month 0-20)

  4. test HIV specific T cell response by ELISPOT

    Measured: 2wk, 4wk, 14wk, 24wk after rTV vaccination

  5. test HIV specific antibody by ELISA

    Measured: 2wk, 4wk, 14wk, 24wk, 48wk after rTV vaccination

  6. Occurrence, intensity and relationship to vaccination of local and general adverse events

    Measured: 28-day follow-up after rTV vaccination

Secondary outcomes (3)

  1. test HIV specific T cell response by ICS

    Measured: 4wk, 8wk, 14wk, 48wk after rTV vaccination

  2. HIV neutralizing antibody test

    Measured: 4wk, 14wk, 48wk after rTV vaccination

  3. vaccinia virus antibody test

    Measured: 2wk, 4wk, 24wk after rTV vaccination

Timeline

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

  1. First posted12 Oct 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionOct 2014
  4. Study completionJan 2015

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01705223
Sponsor's protocol ID
X111012202
Status last verified
Oct 2014
First submitted
12 Sep 2012
Last updated
6 May 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DNA vaccine, DNA vaccine prime with the addition of electroporation and rTV boost in people with AIDS, run by National Center for AIDS/STD Control and Prevention, China CDC 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 5 inclusion and 19 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 6 May 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Occurrence, intensity and relationship to vaccination of local and general adverse events (time frame: 14-day follow-up after DNA vaccine vaccination). The study lists 6 primary outcomes in all. 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 NCT01705223.

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 6 May 2015.

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