Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in HIV-infected Adults

NCT03228069 | Unknown

• 1 other identifier: 1/2017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To study the humoral and cell-mediated immune responses in HIV-infected adults who had previously received rabies booster vaccination more than a year before

Conditions

Rabies

Keywords

rabies vaccination

Outcome Measures

Primary Outcomes (1)

• Rabies Neutralizing Antibody Titers (RNab)

  Rabies Neutralizing Antibody Titers would be represented and compared by geometric mean titers (GMTs)

  GMTs of RNab and proportion of volunteers who have had RNab above protective antibody levels (0.5 IU/ml) after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.

Secondary Outcomes (1)

• Rabies specific T cell response

  Numbers of spots, of which represent the rabies specific T cell response after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.

Other Outcomes (1)

• Rabies specific regulatory T cells

  Numbers of Rabies specific regulatory T cells after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.

Study Arms (2)

single visit 4-site ID vaccination

EXPERIMENTAL

Blood would be drawn from those who received a single visit 4-site ID rabies booster vaccination in the previous trial.

Procedure: Blood drawn after rabies booster vaccination

Conventional IM vaccination

ACTIVE COMPARATOR

Blood would be drawn from those who received a conventional intramuscular rabies booster vaccination in the previous trial.

Procedure: Blood drawn after rabies booster vaccination

Interventions

Blood drawn after rabies booster vaccination PROCEDURE

Blood would be drawn for testing of rabies neutralizing antibody titers, rabies specific T lymphocytes and regulatory T cells after receipt of rabies booster vaccination at least a year before.

Conventional IM vaccination; single visit 4-site ID vaccination

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy HIV-infected adults
• Previously received rabies booster vaccination by participation in the previous clinical trials of the investigators.

You may not qualify if:

• Have any active opportunistic infections
• Received blood or blood product within 3 months
• Received anti-malarial drugs
• Received rabies vaccination in a previous year.

Sponsors & Collaborators

• Queen Saovabha Memorial Institute: lead

Study Sites (1)

Queen Saovabha Memorial Institute

Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Suda Sibunruang, MD

  Queen Saovabha Memorial Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suda Sibunruang, MD

CONTACT

+66 2 2520161; sudapunrin@gmail.com

Terapong Tantawichien, MD

CONTACT

+66 2 2520161; terapong_tantawichien@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Model Details: The volunteers who participated in the previous clinical trials were invited to join this study. Of which, there were 2 groups, one received a single visit 4-site intradermal rabies booster vaccination. The another received a conventional intramuscular rabies booster vaccination on day 0 and 3.

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 24, 2017
• Study Start: August 1, 2017
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)