Trial Outcomes & Findings for Effect of Antimalarial Drugs to Rabies Vaccine for Post-exposure Prophylaxis. (NCT NCT02564471)

Last Updated: 2021-05-13

Results Overview

Chloroquine, Atovaquone and Proguanil (Malarone) and Doxycycline Groups received antimalarial up to day 14 and rabies vaccinations on day 14, 17, 21, and 28 (dose 4). Rabies Group received the rabies vaccination on days 0, 3,7 and 14 (dose 4). Rabies virus-specific serum antibody neutralization assay was used to measure rabies virus antibodies, using the rapid fluorescent foci inhibition test (RFFIT). A titer of \>0.5 IU/ml against rabies virus as protective. Descriptive analyses were based on samples taken 14 days after dose 4, (e.g., at 6 weeks for Chloroquine, Atovaquone and Proguanil (Malarone) and Doxycycline Arms and at 4 weeks for Rabies Arm).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

103 participants

Primary outcome timeframe

6 weeks for Chloroquine, Atovaquone and Proguanil (Malarone) and Doxycycline Groups and at 4 weeks for Rabies Group

Results posted on

2021-05-13

Participant Flow

Healthy adults aged 18 to 60 were recruited from 11-Nov-2016 to 07-Jun-2018 in and around the study site in Syracuse, New York

Participant milestones

Participant milestones
Measure	Chloroquine Chloroquine Phosphate tablet for oral administration 500 mg chloroquine phosphate (equivalent to 300 mg base) Chloroquine: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Atovaquone and Proguanil (Malarone) Malarone tablet for oral administration 250 mg atovaquone and 100 mg proguanil hydrochloride. RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Atovaquone and Proguanil: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Doxycycline Doxycycline hyclate tablet for oral administration, contains specially coated pellets of doxycycline hyclate equivalent to 100 mg of doxycycline. RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Doxycycline: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Rabies RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Rabies Vaccine: FDA approve dosing schedule
Overall Study STARTED	25	26	27	25
Overall Study COMPLETED	22	23	24	25
Overall Study NOT COMPLETED	3	3	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Chloroquine Chloroquine Phosphate tablet for oral administration 500 mg chloroquine phosphate (equivalent to 300 mg base) Chloroquine: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Atovaquone and Proguanil (Malarone) Malarone tablet for oral administration 250 mg atovaquone and 100 mg proguanil hydrochloride. RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Atovaquone and Proguanil: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Doxycycline Doxycycline hyclate tablet for oral administration, contains specially coated pellets of doxycycline hyclate equivalent to 100 mg of doxycycline. RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Doxycycline: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule
Overall Study Adverse Event	1	0	0
Overall Study Withdrawal by Subject	2	1	3
Overall Study Lost to Follow-up	0	2	0

Baseline Characteristics

Group 1: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline; 1 subject was excluded due to use of steroids during the study. Group 2: 3 subjects withdrew. Group 3: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chloroquine n=20 Participants Chloroquine Phosphate tablet for oral administration 500 mg chloroquine phosphate (equivalent to 300 mg base) Chloroquine: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Atovaquone and Proguanil (Malarone) n=23 Participants Malarone tablet for oral administration 250 mg atovaquone and 100 mg proguanil hydrochloride. RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Atovaquone and Proguanil: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Doxycycline n=23 Participants Doxycycline hyclate tablet for oral administration, contains specially coated pellets of doxycycline hyclate equivalent to 100 mg of doxycycline. RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Doxycycline: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Rabies n=25 Participants RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Rabies Vaccine: FDA approve dosing schedule	Total n=91 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants • Group 1: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline; 1 subject was excluded due to use of steroids during the study. Group 2: 3 subjects withdrew. Group 3: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline	0 Participants n=7 Participants • Group 1: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline; 1 subject was excluded due to use of steroids during the study. Group 2: 3 subjects withdrew. Group 3: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline	1 Participants n=5 Participants • Group 1: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline; 1 subject was excluded due to use of steroids during the study. Group 2: 3 subjects withdrew. Group 3: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline	0 Participants n=4 Participants • Group 1: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline; 1 subject was excluded due to use of steroids during the study. Group 2: 3 subjects withdrew. Group 3: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline	2 Participants n=21 Participants • Group 1: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline; 1 subject was excluded due to use of steroids during the study. Group 2: 3 subjects withdrew. Group 3: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants • Group 1: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline; 1 subject was excluded due to use of steroids during the study. Group 2: 3 subjects withdrew. Group 3: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline	23 Participants n=7 Participants • Group 1: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline; 1 subject was excluded due to use of steroids during the study. Group 2: 3 subjects withdrew. Group 3: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline	22 Participants n=5 Participants • Group 1: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline; 1 subject was excluded due to use of steroids during the study. Group 2: 3 subjects withdrew. Group 3: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline	25 Participants n=4 Participants • Group 1: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline; 1 subject was excluded due to use of steroids during the study. Group 2: 3 subjects withdrew. Group 3: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline	89 Participants n=21 Participants • Group 1: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline; 1 subject was excluded due to use of steroids during the study. Group 2: 3 subjects withdrew. Group 3: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline
Age, Categorical >=65 years	0 Participants n=5 Participants • Group 1: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline; 1 subject was excluded due to use of steroids during the study. Group 2: 3 subjects withdrew. Group 3: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline	0 Participants n=7 Participants • Group 1: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline; 1 subject was excluded due to use of steroids during the study. Group 2: 3 subjects withdrew. Group 3: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline	0 Participants n=5 Participants • Group 1: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline; 1 subject was excluded due to use of steroids during the study. Group 2: 3 subjects withdrew. Group 3: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline	0 Participants n=4 Participants • Group 1: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline; 1 subject was excluded due to use of steroids during the study. Group 2: 3 subjects withdrew. Group 3: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline	0 Participants n=21 Participants • Group 1: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline; 1 subject was excluded due to use of steroids during the study. Group 2: 3 subjects withdrew. Group 3: 3 subjects withdrew; 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline
Sex: Female, Male Female	12 Participants n=5 Participants	16 Participants n=7 Participants	13 Participants n=5 Participants	11 Participants n=4 Participants	52 Participants n=21 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	14 Participants n=4 Participants	39 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	20 Participants n=7 Participants	21 Participants n=5 Participants	25 Participants n=4 Participants	85 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	10 Participants n=21 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	20 Participants n=7 Participants	22 Participants n=5 Participants	18 Participants n=4 Participants	78 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	20 Participants n=5 Participants	23 Participants n=7 Participants	23 Participants n=5 Participants	25 Participants n=4 Participants	91 Participants n=21 Participants
Participants with data available at both baseline and post baseline assessments	20 participants n=5 Participants	23 participants n=7 Participants	23 participants n=5 Participants	25 participants n=4 Participants	91 participants n=21 Participants

PRIMARY outcome

Timeframe: 6 weeks for Chloroquine, Atovaquone and Proguanil (Malarone) and Doxycycline Groups and at 4 weeks for Rabies Group

Population: Group 1: 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline, 1 was excluded due to use of steroids during the study; Group 2: 1 subject completed primary endpoint but did not complete the study; Group 3: 1 subject was excluded from analysis due to presence of rabies antibody titer at baseline

Outcome measures

Outcome measures
Measure	Chloroquine n=20 Participants Chloroquine Phosphate tablet for oral administration 500 mg chloroquine phosphate (equivalent to 300 mg base) Chloroquine: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Atovaquone and Proguanil (Malarone) n=24 Participants Malarone tablet for oral administration 250 mg atovaquone and 100 mg proguanil hydrochloride. RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Atovaquone and Proguanil: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Doxycycline n=23 Participants Doxycycline hyclate tablet for oral administration, contains specially coated pellets of doxycycline hyclate equivalent to 100 mg of doxycycline. RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Doxycycline: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Rabies n=25 Participants RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Rabies Vaccine: FDA approve dosing schedule
Geometric Mean Titer (GMT) 14 Days Post Fourth Dose Post Exposure Prophylaxis (PEP) With Purified Chick Embryo Cell Vaccine (PCECV) in Each Malaria Prophylaxis Group Compared to Control to Determine if a Fifth Dose of PEP Would Add Value	3.45 IU/ml Geometric Coefficient of Variation 1.62	7.95 IU/ml Geometric Coefficient of Variation 0.81	8.51 IU/ml Geometric Coefficient of Variation 0.94	10.26 IU/ml Geometric Coefficient of Variation 0.66

SECONDARY outcome

Timeframe: 21 days for Chloroquine, Atovaquone and Proguanil (Malarone) and Doxycycline Groups and 7 days for Rabies Arm

Population: Group 1: 1 subject completed all doses of vaccine but did not complete the study; Group 2: 2 subjects completed all doses of vaccine but did not complete the study.

Chloroquine, Atovaquone and Proguanil (Malarone) and Doxycycline Groups received antimalarial up to day 14 and rabies vaccinations on day 14, 17, 21 (dose 3), and 28 (dose 4). Rabies Group received the rabies vaccination on days 0, 3, 7 (dose 3) and 14 (dose 4). For Chloroquine, Malarone and Doxycycline Groups, samples were taken on days 0, 21, 28 and 56. For Rabies Group, samples were taken on days 0, 7, 14 and 42. Rabies virus-specific serum antibody neutralization assay was used to measure rabies virus antibodies, using the rapid fluorescent foci inhibition test (RFFIT). A titer of \>0.5 IU/ml against rabies virus as protective.

Outcome measures

Outcome measures
Measure	Chloroquine n=21 Participants Chloroquine Phosphate tablet for oral administration 500 mg chloroquine phosphate (equivalent to 300 mg base) Chloroquine: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Atovaquone and Proguanil (Malarone) n=25 Participants Malarone tablet for oral administration 250 mg atovaquone and 100 mg proguanil hydrochloride. RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Atovaquone and Proguanil: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Doxycycline n=23 Participants Doxycycline hyclate tablet for oral administration, contains specially coated pellets of doxycycline hyclate equivalent to 100 mg of doxycycline. RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Doxycycline: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Rabies n=25 Participants RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Rabies Vaccine: FDA approve dosing schedule
GMT Over Protective Titer Prior to Third Dose of PCECV	0.14 IU/ml Geometric Coefficient of Variation 0.62	0.11 IU/ml Geometric Coefficient of Variation 0.40	0.16 IU/ml Geometric Coefficient of Variation 0.72	0.17 IU/ml Geometric Coefficient of Variation 1.15

SECONDARY outcome

Timeframe: 28 days for Chloroquine, Atovaquone and Proguanil (Malarone) and Doxycycline Groups and 14 days for Rabies Arm

Population: Group 1: 1 subject received all doses but did not complete the study; Group 2: 2 subjects received all doses but did not complete the study.

Outcome measures

Outcome measures
Measure	Chloroquine n=21 Participants Chloroquine Phosphate tablet for oral administration 500 mg chloroquine phosphate (equivalent to 300 mg base) Chloroquine: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Atovaquone and Proguanil (Malarone) n=25 Participants Malarone tablet for oral administration 250 mg atovaquone and 100 mg proguanil hydrochloride. RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Atovaquone and Proguanil: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Doxycycline n=23 Participants Doxycycline hyclate tablet for oral administration, contains specially coated pellets of doxycycline hyclate equivalent to 100 mg of doxycycline. RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Doxycycline: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Rabies n=25 Participants RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Rabies Vaccine: FDA approve dosing schedule
GMT Over Protective Titer Prior Fourth Dose of PCECV	4.15 IU/ml Geometric Coefficient of Variation 289	6.45 IU/ml Geometric Coefficient of Variation 1.39	7.04 IU/ml Geometric Coefficient of Variation 2.71	6.98 IU/ml Geometric Coefficient of Variation 1.12

SECONDARY outcome

Timeframe: Up to 8 weeks for Chloroquine, Atovaquone and Proguanil (Malarone) and Doxycycline Groups and up to 6 weeks for Rabies Arm

Chloroquine, Atovaquone and Proguanil (Malarone) and Doxycycline Groups received antimalarial up to day 14 and rabies vaccinations on day 14, 17, 21 (dose 3), and 28 (dose 4). Rabies Group received the rabies vaccination on days 0, 3,7 (dose 3) and 14 (dose 4). For Chloroquine, Malarone and Doxycycline Groups, samples were taken on days 0, 21, 28 and 56. For Rabies Group, samples were taken on days 0, 7, 14 and 42. Rabies virus-specific serum antibody neutralization assay was used to measure rabies virus antibodies, using the rapid fluorescent foci inhibition test (RFFIT). A titer of \>0.5 IU/ml against rabies virus as protective.

Outcome measures

Outcome measures
Measure	Chloroquine n=20 Participants Chloroquine Phosphate tablet for oral administration 500 mg chloroquine phosphate (equivalent to 300 mg base) Chloroquine: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Atovaquone and Proguanil (Malarone) n=23 Participants Malarone tablet for oral administration 250 mg atovaquone and 100 mg proguanil hydrochloride. RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Atovaquone and Proguanil: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Doxycycline n=23 Participants Doxycycline hyclate tablet for oral administration, contains specially coated pellets of doxycycline hyclate equivalent to 100 mg of doxycycline. RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Doxycycline: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Rabies n=25 Participants RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Rabies Vaccine: FDA approve dosing schedule
GMT Over Protective Titer 28 Days Post Fourth Dose of PCECV	2.3 IU/ml Geometric Coefficient of Variation 1.53	4.96 IU/ml Geometric Coefficient of Variation 0.78	5.18 IU/ml Geometric Coefficient of Variation 1.14	6.87 IU/ml Geometric Coefficient of Variation 1.04

Adverse Events

Chloroquine

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Atovaquone and Proguanil (Malarone)

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Doxyclycline

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Rabies

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Chloroquine n=25 participants at risk Chloroquine Phosphate tablet for oral administration 500 mg chloroquine phosphate (equivalent to 300 mg base) Chloroquine: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Atovaquone and Proguanil (Malarone) n=26 participants at risk Malarone tablet for oral administration 250 mg atovaquone and 100 mg proguanil hydrochloride. RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Atovaquone and Proguanil: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Doxyclycline n=27 participants at risk Doxycycline hyclate tablet for oral administration, contains specially coated pellets of doxycycline hyclate equivalent to 100 mg of doxycycline. RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Doxycycline: FDA approve dosing schedule Rabies Vaccine: FDA approve dosing schedule	Rabies n=25 participants at risk RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Rabies Vaccine: FDA approve dosing schedule
Gastrointestinal disorders Abdominal Pain	16.0% 4/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	13.0% 3/23 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	0.00% 0/23 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	0.00% 0/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.
Gastrointestinal disorders Nausea	20.0% 4/20 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	15.4% 4/26 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	26.1% 6/23 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	16.0% 4/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.
General disorders Injection site reaction	36.0% 9/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	42.3% 11/26 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	37.0% 10/27 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	52.0% 13/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.
Musculoskeletal and connective tissue disorders Myalgia	12.0% 3/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	15.4% 4/26 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	11.1% 3/27 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	4.0% 1/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.
General disorders Flu like symptoms	12.0% 3/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	3.8% 1/26 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	7.4% 2/27 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	8.0% 2/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.
Infections and infestations Upper Respiratory Infection	4.0% 1/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	15.4% 4/26 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	7.4% 2/27 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	16.0% 4/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.
Nervous system disorders Headache	16.0% 4/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	34.6% 9/26 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	25.9% 7/27 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	12.0% 3/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.
General disorders Fatigue	4.0% 1/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	3.8% 1/26 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	14.8% 4/27 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	0.00% 0/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.
Gastrointestinal disorders Diarrhea	20.0% 5/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	19.2% 5/26 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	7.4% 2/27 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	0.00% 0/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.
Nervous system disorders Dizziness	8.0% 2/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	3.8% 1/26 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	3.7% 1/27 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	0.00% 0/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.
Respiratory, thoracic and mediastinal disorders Laryngeal Inflammation	4.0% 1/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	7.7% 2/26 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	3.7% 1/27 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	0.00% 0/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.
Gastrointestinal disorders Vomiting	4.0% 1/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	11.5% 3/26 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	3.7% 1/27 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	4.0% 1/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.
Injury, poisoning and procedural complications Burn	0.00% 0/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	0.00% 0/26 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	7.4% 2/27 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.	0.00% 0/25 • 8 weeks from Chloroquine, Malarone/Atovaquone, Doxycyline groups, 6 weeks for rabies control group.

Additional Information

Dr. Timothy Endy

SUNY Upstate Medical University

Phone: 3154647692

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place