Rabies Vaccination of 6-Week-Old Puppies Born to Immunized Mothers: A Randomized Controlled Trial in a High-Mortality Population of Owned, Free-Roaming Dogs
Abstract
:1. Introduction
2. Methods
2.1. Study Design
2.2. Study Population
2.3. Treatment Group Allocation and Blinding
2.4. Baseline Characteristics
2.5. Follow Up
2.6. Immunogenicity
2.7. Sample Size and Statistical Analysis
3. Results
3.1. Immunogenicity
3.2. Survival Analysis
4. Discussion
Supplementary Materials
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Characteristic | Sterile Water (SW) | Rabies Vaccine (RV) |
---|---|---|
Number allocated | 179 | 179 |
Demographics | ||
Male, n (%) | 93 (52.0) | 91 (50.8) |
Age in days, median (range) | 42 (40–45) | 42 (39–45) |
Dam days between vaccination and birth, median (range) a | 208 (3–555) | 211 (5–555) |
Housing | ||
Primary caretaker, n (%) | ||
All members of household | 97 (54.2) | 94 (52.5) |
Head of household | 57 (31.8) | 61 (34.1) |
Children | 20 (11.2) | 16 (8.9) |
Other | 2 (1.1) | 5 (2.8) |
No response | 3 (1.7) | 3 (1.7) |
Housing type, n (%) | ||
Mostly inside | 116 (64.8) | 116 (64.8) |
Mostly outside | 47 (26.3) | 50 (27.9) |
Other | 13 (7.3) | 10 (5.6) |
No response | 3 (1.7) | 3 (1.7) |
Health | ||
Owner-reported growth, n (%) | ||
Normal weight-gain | 148 (82.7) | 151 (84.4) |
Less than expected weight-gain | 22 (12.3) | 20 (11.2) |
Other | 6 (3.4) | 5 (2.8) |
No response | 3 (1.7) | 3 (1.7) |
Weight in grams, mean (sd) b | 2037 (699) | 2031 (731) |
Packed cell volume, mean (sd) c | 23.0 (5.4) | 22.9 (5.4) |
Total protein in g/dL, mean (sd) d | 5.2 (0.7) | 5.2 (0.7) |
RVNA titres in IU/mL, geometric mean (gsd) e | 0.07 (1.90) | 0.06 (1.79) |
Percent with RVNA titres ≥0.5 IU/mL e | 3.5 | 1.7 |
Control Group (SW at 6 Weeks + RV at 13 Weeks) | Treatment Group (RV at 6 Weeks + RV at 13 Weeks) | |||||
---|---|---|---|---|---|---|
Age | n | GMT in IU/mL (95% CI) | Seroresponse (95% CI) | n | GMT in IU/mL (95% CI) | Seroresponse (95% CI) |
6 weeks | 173 | 0.066 (0.060–0.073) | 3.5% (1.3–7.4) | 173 | 0.064 (0.059–0.070) | 1.7% (0.4–4.0) |
9 weeks | 106 | 0.064 (0.057–0.071) | 2.8% (0.6–8.0) | 117 | 1.47 (1.19–1.83) | 88.0% (80.7–93.3) |
16 weeks | 50 | 1.18 (0.80–1.74) | 84.0% (70.9–92.8) | 49 | 2.73 (1.83–4.06) | 91.8% (80.4–97.7) |
Primary Vaccination Timepoint | GMT in IU/mL (95% CI) | Seroresponse (95% CI) | ||||
---|---|---|---|---|---|---|
Females | Males | p-Value | Females | Males | p-Value | |
6 weeks (treatment group) | 1.53 (1.15–2.05) | 1.42 (1.03–1.96) | 0.71 | 89.1% (77.8–95.9) | 87.1% (76.1–94.3) | 0.78 |
13 weeks (control group) | 1.51 (0.93–2.45) | 0.90 (0.48–1.70) | 0.20 | 88.5% (69.8–97.6) | 79.2% (57.8–92.9) | 0.46 |
Sterile Water | Rabies Vaccine | HRs (95% CI) for RV within Strata of Sex | |||
---|---|---|---|---|---|
Mortality Rate a (Deaths/Dog-Years) | HR (95% CI) b | Mortality rate a (Deaths/Dog-Years) | HR (95% CI) b | ||
Females | 844 (7/8.3) | 1 (reference) | 2813 (24/8.5) | 3.09 (1.24−7.69) | 3.09 (1.24−7.69) |
Males | 3030 (26/8.6) | 3.67 (1.43−9.39) | 2525 (23/9.1) | 2.89 (1.18−7.11) | 0.79 (0.41−1.53) |
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Arega, S.; Conan, A.; Sabeta, C.T.; Crafford, J.E.; Wentzel, J.; Reininghaus, B.; Biggs, L.; Leisewitz, A.L.; Quan, M.; Toka, F.; et al. Rabies Vaccination of 6-Week-Old Puppies Born to Immunized Mothers: A Randomized Controlled Trial in a High-Mortality Population of Owned, Free-Roaming Dogs. Trop. Med. Infect. Dis. 2020, 5, 45. https://doi.org/10.3390/tropicalmed5010045
Arega S, Conan A, Sabeta CT, Crafford JE, Wentzel J, Reininghaus B, Biggs L, Leisewitz AL, Quan M, Toka F, et al. Rabies Vaccination of 6-Week-Old Puppies Born to Immunized Mothers: A Randomized Controlled Trial in a High-Mortality Population of Owned, Free-Roaming Dogs. Tropical Medicine and Infectious Disease. 2020; 5(1):45. https://doi.org/10.3390/tropicalmed5010045
Chicago/Turabian StyleArega, Sintayehu, Anne Conan, Claude T. Sabeta, Jan E. Crafford, Jeanette Wentzel, Bjorn Reininghaus, Louise Biggs, Andrew L. Leisewitz, Melvyn Quan, Felix Toka, and et al. 2020. "Rabies Vaccination of 6-Week-Old Puppies Born to Immunized Mothers: A Randomized Controlled Trial in a High-Mortality Population of Owned, Free-Roaming Dogs" Tropical Medicine and Infectious Disease 5, no. 1: 45. https://doi.org/10.3390/tropicalmed5010045