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

May 5, 2015 updated by: National Center for AIDS/STD Control and Prevention, China CDC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Beijing youan hospital，capital medical university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
    • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: group A
DNA vaccine prime at week 0,4,8 and rTV boost at week 16
Biological: DNA vaccine
4mg/dose, three doses at week 0,4,8
Biological: rTV boost
at week 16
Biological: rTV boost
at week 24
Biological: rTV boost
at week 32
Experimental: group B
DNA vaccine prime at week 0,4,8 and rTV boost at week 24
Biological: DNA vaccine
4mg/dose, three doses at week 0,4,8
Biological: rTV boost
at week 16
Biological: rTV boost
at week 24
Biological: rTV boost
at week 32
Experimental: group C
DNA vaccine prime at week 0,4,8 and rTV boost at week 32
Biological: DNA vaccine
4mg/dose, three doses at week 0,4,8
Biological: rTV boost
at week 16
Biological: rTV boost
at week 24
Biological: rTV boost
at week 32
Experimental: group D
DNA vaccine prime with the addition of electroporation at week 0, 4, 8 and rTV boost at week 24
Biological: rTV boost
at week 16
Biological: rTV boost
at week 24
Biological: rTV boost
at week 32
Biological: DNA vaccine prime with the addition of electroporation
4mg/dose, three doses at week 0,4,8

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Occurrence, intensity and relationship to vaccination of local and general adverse events
Time Frame: 14-day follow-up after DNA vaccine vaccination
14-day follow-up after DNA vaccine vaccination
Occurrence and relationship to vaccination of any serious AEs (SAEs)
Time Frame: During the study period (Month 0-20)
During the study period (Month 0-20)
Occurrence, intensity and relationship to vaccination of clinically significant abnormal haematology and biochemistry values (grade 4)
Time Frame: During the study period (Month 0-20)
During the study period (Month 0-20)
test HIV specific T cell response by ELISPOT
Time Frame: 2wk, 4wk, 14wk, 24wk after rTV vaccination
2wk, 4wk, 14wk, 24wk after rTV vaccination
test HIV specific antibody by ELISA
Time Frame: 2wk, 4wk, 14wk, 24wk, 48wk after rTV vaccination
2wk, 4wk, 14wk, 24wk, 48wk after rTV vaccination
Occurrence, intensity and relationship to vaccination of local and general adverse events
Time Frame: 28-day follow-up after rTV vaccination
28-day follow-up after rTV vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
test HIV specific T cell response by ICS
Time Frame: 4wk, 8wk, 14wk, 48wk after rTV vaccination
4wk, 8wk, 14wk, 48wk after rTV vaccination
HIV neutralizing antibody test
Time Frame: 4wk, 14wk, 48wk after rTV vaccination
4wk, 14wk, 48wk after rTV vaccination
vaccinia virus antibody test
Time Frame: 2wk, 4wk, 24wk after rTV vaccination
2wk, 4wk, 24wk after rTV vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Center for AIDS/STD Control and Prevention, China CDC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hao Wu, M.D., Beijing Youan Hospital
  • Principal Investigator: Tong Zhang, M.D., Beijing Youan Hospital
  • Principal Investigator: Yiming Shao, Ph.D., NCAIDS, China CDC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • X111012202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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