Phase 3 N=885 Randomized Prevention

Safety and Immunogenicity of Two Intradermal Rabies Vaccine Regimens Administered With and Without Human Rabies Immunoglobulin in Subjects ≥ 1 Years of Age

Rabies Infection

Bottom Line

View on ClinicalTrials.gov: NCT02177032 ↗

Enrolled (actual)

885

Serious AEs

1.4%

Results posted

Apr 2017

Primary outcome: Primary: Percentages of Subjects With RVNA Titer >= 0.5 and Vaccine Group Differences ("4-sites, 1-week" to That of "2-sites, TRC" ID PEP Regimen of the PCEC Rabies Vaccine With or Without HRIG Administration) — 99; 100 Percentages of Subjects

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Rabies vaccine (Biological); Rabies vaccines + Rabies immunoglobulins (Biological)
Age: Pediatric, Adult, Older Adult · 1+ yrs
Sex: All
Sponsor: Novartis
Primary completion: Oct 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentages of Subjects With RVNA Titer >= 0.5 and Vaccine Group Differences ("4-sites, 1-week" to That of "2-sites, TRC" ID PEP Regimen of the PCEC Rabies Vaccine With or Without HRIG Administration)	99; 100	—
SECONDARY Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Between-group (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC) With or Without HRIG) Ratio of GMCs	4.58; 10	—
SECONDARY Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age	0.23; 0.14; 18; 12; 2.32; 3.68	—
SECONDARY Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age	18; 10; 100; 100; 96; 99	—
SECONDARY Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age	0.21; 0.15; 13; 15; 1.97; 4.47	—
SECONDARY Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age	0; 0; 8; 10; 100; 99	—
SECONDARY Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age	0.05; 0.05; 0.23; 0.13; 19; 12	—
SECONDARY Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age	21; 10; 100; 100; 100; 100	—
SECONDARY Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination	0; NA; 0; NA; 0; NA	—
SECONDARY Number of Subjects Reporting Unsolicited Adverse Events (AEs)	45; NA; 53; NA; 3; NA	—
SECONDARY Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age	0.05; 0.05; 0.21; 0.17; 13; 8.37	—
SECONDARY Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age	0; 0; 8; 10; 100; 99	—

Summary

Demonstrate non-inferiority of the immune response between new versus the currently recommended intradermal regimens of rabies vaccine when administered with or without rabies immunoglobulins in healthy subjects ≥ 1 years of age.

Eligibility Criteria

Inclusion Criteria

Healthy males and females ≥ 1 years of age
Individuals/ individual's parents or legal guardians who have given written consent
Individuals in good health
Individuals who can comply with study procedures

Exclusion Criteria

Behavioral or cognitive impairment or psychiatric disease.
Unable to comprehend and to follow all required study procedures for the whole period of the study.
History of illness or with an ongoing illness that may pose additional risk to the individual if he/she participates in the study.
Individuals ≥ 1 to ≤ 17 years of age, who have or ever had a malignancy.
Individuals ≥ 18 years of age, who have or who within the last 5 years, have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder.
Known or suspected impairment of the immune system (including but not limited to HIV, autoimmune disorders, immunosuppressive therapy as applicable).
Female of childbearing potential who has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry.
Female of childbearing potential, refusal to use an "acceptable birth control method" through day 50.
Female of childbearing potential, with a positive pregnancy test prior to enrollment.
Received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the previous 12 weeks.
Allergic to any of the vaccine components.
Allergic to any of the human rabies immunoglobulin components.
Contraindication or precaution against rabies vaccination.
Contraindication or precaution against man rabies immunoglobulin administration.
Planning to receive anti-malaria medications (e.g. Mefloquine) 14 days prior to day 1 vaccination through day 50.
Participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
Body temperature ≥ 38.0°C (≥ 100.4°F) within 3 days of intended study vaccination.
Received rabies vaccines or rabies immunoglobulin or have been exposed to rabies.
Part of the study personnel or immediate family members of study personnel conducting this study.
Current or history of drug or alcohol abuse within the past 2 years.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02177032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.