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

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

885 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Rabies Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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4-sites, 1-week without HRIG

PCEC rabies vaccine, administered ID according to the "4-sites, 1-week" regimen

Group Type EXPERIMENTAL

Rabies vaccine

Intervention Type BIOLOGICAL

12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8).

4-sites, 1-week with HRIG

PCEC rabies vaccine, administered ID to adults, according to the "4-sites, 1-week" regimen plus HRIG

Group Type EXPERIMENTAL

Rabies vaccines + Rabies immunoglobulins

Intervention Type BIOLOGICAL

12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8). HRIG will be administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly into the gluteal muscle.

2-sites, TRC without HRIG

PCEC rabies vaccine, administered ID according to the "2-sites, TRC" regimen

Group Type ACTIVE_COMPARATOR

Rabies vaccine

Intervention Type BIOLOGICAL

8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen (i.e. 2 doses of vaccine; in both deltoids, administered on days 1, 4, 8, and 29).

2-sites, TRC with HRIG

PCEC rabies vaccine, administered ID to adults , according to the "2-sites, TRC" regimen plus HRIG

Group Type ACTIVE_COMPARATOR

Rabies vaccines + Rabies immunoglobulins

Intervention Type BIOLOGICAL

8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen (i.e. 2 doses of vaccine; in both deltoids, administered on days 1, 4, 8, and 29). HRIG will be administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly into the gluteal muscle.

Interventions

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Rabies vaccine

12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8).

Intervention Type BIOLOGICAL

Rabies vaccines + Rabies immunoglobulins

12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8). HRIG will be administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly into the gluteal muscle.

Intervention Type BIOLOGICAL

Rabies vaccine

8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen (i.e. 2 doses of vaccine; in both deltoids, administered on days 1, 4, 8, and 29).

Intervention Type BIOLOGICAL

Rabies vaccines + Rabies immunoglobulins

8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen (i.e. 2 doses of vaccine; in both deltoids, administered on days 1, 4, 8, and 29). HRIG will be administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly into the gluteal muscle.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Behavioral or cognitive impairment or psychiatric disease.
2. Unable to comprehend and to follow all required study procedures for the whole period of the study.
3. History of illness or with an ongoing illness that may pose additional risk to the individual if he/she participates in the study.
4. Individuals ≥ 1 to ≤ 17 years of age, who have or ever had a malignancy.
5. 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.
6. Known or suspected impairment of the immune system (including but not limited to HIV, autoimmune disorders, immunosuppressive therapy as applicable).
7. Female of childbearing potential who has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry.
8. Female of childbearing potential, refusal to use an "acceptable birth control method" through day 50.
9. Female of childbearing potential, with a positive pregnancy test prior to enrollment.
10. Received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the previous 12 weeks.
11. Allergic to any of the vaccine components.
12. Allergic to any of the human rabies immunoglobulin components.
13. Contraindication or precaution against rabies vaccination.
14. Contraindication or precaution against man rabies immunoglobulin administration.
15. Planning to receive anti-malaria medications (e.g. Mefloquine) 14 days prior to day 1 vaccination through day 50.
16. 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.
17. 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.
18. Body temperature ≥ 38.0°C (≥ 100.4°F) within 3 days of intended study vaccination.
19. Received rabies vaccines or rabies immunoglobulin or have been exposed to rabies.
20. Part of the study personnel or immediate family members of study personnel conducting this study.
21. Current or history of drug or alcohol abuse within the past 2 years.

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes