NCT01705223

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 12, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

May 6, 2015

Status Verified

October 1, 2014

Enrollment Period

2.2 years

First QC Date

September 12, 2012

Last Update Submit

May 5, 2015

Conditions

AIDS

Keywords

prophylacticvaccine

Outcome Measures

Primary Outcomes (6)

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

    14-day follow-up after DNA vaccine vaccination

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

    During the study period (Month 0-20)

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

    During the study period (Month 0-20)

  • test HIV specific T cell response by ELISPOT

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

  • test HIV specific antibody by ELISA

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

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

    28-day follow-up after rTV vaccination

Secondary Outcomes (3)

  • test HIV specific T cell response by ICS

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

  • HIV neutralizing antibody test

    4wk, 14wk, 48wk after rTV vaccination

  • vaccinia virus antibody test

    2wk, 4wk, 24wk after rTV vaccination

Study Arms (4)

group A

EXPERIMENTAL

DNA vaccine prime at week 0,4,8 and rTV boost at week 16

Biological: DNA vaccineBiological: rTV boost

group B

EXPERIMENTAL

DNA vaccine prime at week 0,4,8 and rTV boost at week 24

Biological: DNA vaccineBiological: rTV boost

group C

EXPERIMENTAL

DNA vaccine prime at week 0,4,8 and rTV boost at week 32

Biological: DNA vaccineBiological: rTV boost

group D

EXPERIMENTAL

DNA vaccine prime with the addition of electroporation at week 0, 4, 8 and rTV boost at week 24

Biological: DNA vaccine prime with the addition of electroporationBiological: rTV boost

Interventions

DNA vaccineBIOLOGICAL

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

group Agroup Bgroup C
DNA vaccine prime with the addition of electroporationBIOLOGICAL

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

group D
rTV boostBIOLOGICAL

at week 16

group A

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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：
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Youan Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Vaccines, DNA

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acid-Based VaccinesVaccines, SyntheticRecombinant ProteinsProteinsAmino Acids, Peptides, and ProteinsVaccinesBiological ProductsComplex MixturesAntigensBiological Factors

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2012

First Posted

October 12, 2012

Study Start

August 1, 2012

Primary Completion

October 1, 2014

Study Completion

January 1, 2015

Last Updated

May 6, 2015

Record last verified: 2014-10

Locations

CN(1)