Trial Outcomes & Findings for H1N1 Influenza Vaccine Immunogenicity in HIV-1 Infected Patients (NCT NCT01111162)

Last Updated: 2016-07-12

Results Overview

To assess the safety of inactivated swine-origin H1N1 influenza vaccine in HIV-1 infected individuals (received as part of standard of care). Safety was assessed via 1. Adverse Events of Grade 3 or higher of abnormal laboratory values, signs and symptoms or diagnoses. 2. Solicited local AEs, including pain, tenderness, redness, and swelling post each vaccination. Solicited systemic AEs, including feverishness, malaise, body aches (exclusive of the injection site), nausea, and headache post each vaccination.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

120 participants

Primary outcome timeframe

21-28 days

Results posted on

2016-07-12

Participant Flow

The study was conducted at the MacGregor Clinic of the Hospital of the University of Pennsylvania in Philadelphia, Pennsylvania, USA, between the months of November and January 2009-2010. All patients signed an informed consent. The study was approved by the University of Pennsylvania institutional review board .

Participant milestones

Participant milestones
Measure	Vaccine Arm (Single Arm) 15 µg dose of the monovalent, unadjuvanted, inactivated, split virus H1N1 vaccine (Novartis, Basel, Switzerland).
Overall Study STARTED	120
Overall Study COMPLETED	120
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

H1N1 Influenza Vaccine Immunogenicity in HIV-1 Infected Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vaccination Group (Single Arm Study) n=120 Participants All participants
Age, Continuous	46 years n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	85 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	113 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	81 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Percentage of Participants at Baseline with HAI assay titers ≥ 1:40	25 percentage of participants n=5 Participants

PRIMARY outcome

Timeframe: 21-28 days

Outcome measures

Outcome measures
Measure	Vacinees n=120 Participants
Safety Pain	22 percentage of participants
Safety Redness	3 percentage of participants
Safety Induration	0 percentage of participants
Safety Tenderness	18 percentage of participants
Safety Ecymosis	0 percentage of participants
Safety Headache	16 percentage of participants
Safety Malaise	19 percentage of participants
Safety Myalgia	18 percentage of participants
Safety Nausea	4 percentage of participants
Safety Chills	3 percentage of participants
Safety Vomiting	1 percentage of participants
Safety Fever	1 percentage of participants

PRIMARY outcome

Timeframe: 21-28 days

Population: Among the 90 participants without evidence of previous exposure to H1N1, only 61% \[95% confidence interval (CI) 51-71\] developed protective titers by week 3 of the study (seroconversion rate).

Immunologic response, defined as HAI titer ≥ 1:40, at 21 days after vaccine dose.

Outcome measures

Outcome measures
Measure	Vacinees n=90 Participants
Immunogenicity	61 percentage of seroconversion Interval 51.0 to 71.0

Adverse Events

Vaccine Arm (Single Arm)

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vaccine Arm (Single Arm) n=120 participants at risk 15 µg dose of the monovalent, unadjuvanted, inactivated, split virus H1N1 vaccine (Novartis, Basel, Switzerland).
General disorders Pain at Injection Site	21.7% 26/120 • Duration of the study (21-28 days) Serious adverse events include all Grade 3 or greater adverse events
General disorders Redness at Injection Site	3.3% 4/120 • Duration of the study (21-28 days) Serious adverse events include all Grade 3 or greater adverse events
General disorders Tenderness at Injection Site	18.3% 22/120 • Duration of the study (21-28 days) Serious adverse events include all Grade 3 or greater adverse events
General disorders Headache	15.8% 19/120 • Duration of the study (21-28 days) Serious adverse events include all Grade 3 or greater adverse events
General disorders Malaise	19.2% 23/120 • Duration of the study (21-28 days) Serious adverse events include all Grade 3 or greater adverse events
General disorders Myalgia	18.3% 22/120 • Duration of the study (21-28 days) Serious adverse events include all Grade 3 or greater adverse events
General disorders Nausea	4.2% 5/120 • Duration of the study (21-28 days) Serious adverse events include all Grade 3 or greater adverse events
General disorders Chills	2.5% 3/120 • Duration of the study (21-28 days) Serious adverse events include all Grade 3 or greater adverse events
General disorders Vomiting	0.83% 1/120 • Duration of the study (21-28 days) Serious adverse events include all Grade 3 or greater adverse events
General disorders Fever	0.83% 1/120 • Duration of the study (21-28 days) Serious adverse events include all Grade 3 or greater adverse events

Additional Information

Pablo Tebas

University of Pennsylvania

Phone: 2153498092

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place