Trial Outcomes & Findings for Immune Response After Booster Vaccination in HIV - Infected Patients Who Received Rabies Primary Vaccination (NCT NCT01286493)

Results Overview

Rabies Neutralizing Antibody titers(RNab)of HIV-infected patients who receive booster rabies vaccination would be measured by Rapid Fluorescent Focus Inhibition Test(RFFIT) method at day 0, 7, 14, 28, 90,180 and 360. RNab level above 0.5 IU/ml indicate acceptable protective antibody response. for 7 times in 1 year.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

Day 360

Results posted on

2015-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	Rabies Vaccines on Day 0 and 3 Cell culture Rabies vaccines on day 0 and 3 rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360
Overall Study STARTED	33
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immune Response After Booster Vaccination in HIV - Infected Patients Who Received Rabies Primary Vaccination

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rabies Vaccines on Day 0 and 3 n=33 Participants Cell culture Rabies vaccines on day 0 and 3 rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360
Age, Continuous	43 years STANDARD_DEVIATION 7.8 • n=93 Participants
Sex: Female, Male Female	13 Participants n=93 Participants
Sex: Female, Male Male	20 Participants n=93 Participants
Region of Enrollment Thailand	33 participants n=93 Participants
CD4+ T lymphocyte counts	489 cell/mm^3 n=93 Participants

PRIMARY outcome

Timeframe: Day 360

Population: As preliminary study, the number of participants was estimated to be above 15 - 20 cases.

Rabies Neutralizing Antibody titers(RNab)of HIV-infected patients who receive booster rabies vaccination would be measured by Rapid Fluorescent Focus Inhibition Test(RFFIT) method at day 0, 7, 14, 28, 90,180 and 360. RNab level above 0.5 IU/ml indicate acceptable protective antibody response. for 7 times in 1 year.

Outcome measures

Outcome measures
Measure	Rabies Vaccines on Day 0 and 3 n=33 Participants Cell culture Rabies vaccines on day 0 and 3 rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360
Rabies Neutralizing Antibody Titers	8.48 IU/ml Interval 0.5 to 218.1

Adverse Events

Rabies Vaccines on Day 0 and 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Suda Sibunruang

Queen Saovabha Memorial Institute

Phone: +66 2 2520161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place