Safety and immunogenicity of the DTP/HB /Hib combination vaccine: phase I study
Background The World Health Organization (WHO) has recommended the introduction ofhepatitis B (HB) and Haemophilus influenza type b (Hib) vaccines into routine childhood vaccination programs. A new diptheria/tetanus/pertussis (DTP) /hepatitis B/Hib pentavalent combination vaccine has been developed....
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| Format: | Article |
| Language: | English |
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Indonesian Pediatric Society Publishing House
2013-12-01
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| Series: | Paediatrica Indonesiana |
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| Online Access: | https://paediatricaindonesiana.org/index.php/paediatrica-indonesiana/article/view/368 |
| _version_ | 1811286815669223424 |
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| author | Kusnandi Rusmil Eddy Fadlyana Novilia Sjafri Bachtiar Hadyana Hadyana |
| author_facet | Kusnandi Rusmil Eddy Fadlyana Novilia Sjafri Bachtiar Hadyana Hadyana |
| author_sort | Kusnandi Rusmil |
| collection | DOAJ |
| description | Background The World Health Organization (WHO) has
recommended the introduction ofhepatitis B (HB) and Haemophilus
influenza type b (Hib) vaccines into routine childhood vaccination
programs. A new diptheria/tetanus/pertussis (DTP) /hepatitis B/Hib
pentavalent combination vaccine has been developed.
Objective To evaluate the safety and immunogenicity of a new
combination DTP/HB/Hib liquid vaccin e in infants.
Met hods An open-label, uncontrolled, prospective intervention
phase I study was con ducted on 30 healthy infants aged 6- 11
weeks. Each subject received 3 doses of DTP/HB/Hib vaccine,
formulated by Bio Fanna, 0.5 mL intramuscularly at the left
anterolateral thigh region using a 25-gauge n eedle of 25 mm
length . Subjects were followed for 1 month after administration of
each vaccine dose to evaluate its safety, while serum anti-diphteria,
tetanus, HB, Hib, and per tussis antibodies were measured prior
to the l '' dose and 1 month after the Jtd dose.
Results Among 30 vaccinated subjects, 18 infants had fever within
24 hours after the first vaccination. Most cases of fever were mild
in intensity and resolved within 24 hours. No other systemic or
local reactions, or serious adverse events were observed in our
subjects during the study. The immunogenicity results after Jtd
vaccine dose showed that the geometric mean titer of the antipolyribosylribitol
phosphate (PRP) antibody levels increased
significantly from 0.0041μ,g/mL to 4.3 7 μ,g/mL after vaccination,
and most infants h ad a fourfo ld or greater rise in antibody levels
over their pre-injection levels . All subjects who received DTP/
HB/Hib liquid vaccine had seropro tective antibodies against
tetanus, diphtheria,a and hepatitis B, while 29/30 infants had
seroprotective antibodies against pertussis.
Conclusion This new diphtheria/tetanus/pertusis/hepatitis B/Hib
combination vaccine has excellent safety profile and antibody
responses in infants. These results encourage further clinical
evaluation in phase II. |
| first_indexed | 2024-04-13T03:06:31Z |
| format | Article |
| id | doaj.art-65c898eac62c459d9c7d99b61a1c0b11 |
| institution | Directory Open Access Journal |
| issn | 0030-9311 2338-476X |
| language | English |
| last_indexed | 2024-04-13T03:06:31Z |
| publishDate | 2013-12-01 |
| publisher | Indonesian Pediatric Society Publishing House |
| record_format | Article |
| series | Paediatrica Indonesiana |
| spelling | doaj.art-65c898eac62c459d9c7d99b61a1c0b112022-12-22T03:05:13ZengIndonesian Pediatric Society Publishing HousePaediatrica Indonesiana0030-93112338-476X2013-12-015363091410.14238/pi53.6.2013.309-14260Safety and immunogenicity of the DTP/HB /Hib combination vaccine: phase I studyKusnandi Rusmil0Eddy Fadlyana1Novilia Sjafri Bachtiar2Hadyana Hadyana3Department of Child Health, Padjadjaran University Medical School Hasan Sadikin Hospital BandungDepartment of Child Health, Padjadjaran University Medical School Hasan Sadikin Hospital BandungDepartment of Child Health, Padjadjaran University Medical School Hasan Sadikin Hospital BandungDepartment of Child Health, Padjadjaran University Medical School Hasan Sadikin Hospital BandungBackground The World Health Organization (WHO) has recommended the introduction ofhepatitis B (HB) and Haemophilus influenza type b (Hib) vaccines into routine childhood vaccination programs. A new diptheria/tetanus/pertussis (DTP) /hepatitis B/Hib pentavalent combination vaccine has been developed. Objective To evaluate the safety and immunogenicity of a new combination DTP/HB/Hib liquid vaccin e in infants. Met hods An open-label, uncontrolled, prospective intervention phase I study was con ducted on 30 healthy infants aged 6- 11 weeks. Each subject received 3 doses of DTP/HB/Hib vaccine, formulated by Bio Fanna, 0.5 mL intramuscularly at the left anterolateral thigh region using a 25-gauge n eedle of 25 mm length . Subjects were followed for 1 month after administration of each vaccine dose to evaluate its safety, while serum anti-diphteria, tetanus, HB, Hib, and per tussis antibodies were measured prior to the l '' dose and 1 month after the Jtd dose. Results Among 30 vaccinated subjects, 18 infants had fever within 24 hours after the first vaccination. Most cases of fever were mild in intensity and resolved within 24 hours. No other systemic or local reactions, or serious adverse events were observed in our subjects during the study. The immunogenicity results after Jtd vaccine dose showed that the geometric mean titer of the antipolyribosylribitol phosphate (PRP) antibody levels increased significantly from 0.0041μ,g/mL to 4.3 7 μ,g/mL after vaccination, and most infants h ad a fourfo ld or greater rise in antibody levels over their pre-injection levels . All subjects who received DTP/ HB/Hib liquid vaccine had seropro tective antibodies against tetanus, diphtheria,a and hepatitis B, while 29/30 infants had seroprotective antibodies against pertussis. Conclusion This new diphtheria/tetanus/pertusis/hepatitis B/Hib combination vaccine has excellent safety profile and antibody responses in infants. These results encourage further clinical evaluation in phase II.https://paediatricaindonesiana.org/index.php/paediatrica-indonesiana/article/view/368DTP/HB/Hib vaccine, safety, immunogenicity, phase I |
| spellingShingle | Kusnandi Rusmil Eddy Fadlyana Novilia Sjafri Bachtiar Hadyana Hadyana Safety and immunogenicity of the DTP/HB /Hib combination vaccine: phase I study Paediatrica Indonesiana DTP/HB/Hib vaccine, safety, immunogenicity, phase I |
| title | Safety and immunogenicity of the DTP/HB /Hib combination vaccine: phase I study |
| title_full | Safety and immunogenicity of the DTP/HB /Hib combination vaccine: phase I study |
| title_fullStr | Safety and immunogenicity of the DTP/HB /Hib combination vaccine: phase I study |
| title_full_unstemmed | Safety and immunogenicity of the DTP/HB /Hib combination vaccine: phase I study |
| title_short | Safety and immunogenicity of the DTP/HB /Hib combination vaccine: phase I study |
| title_sort | safety and immunogenicity of the dtp hb hib combination vaccine phase i study |
| topic | DTP/HB/Hib vaccine, safety, immunogenicity, phase I |
| url | https://paediatricaindonesiana.org/index.php/paediatrica-indonesiana/article/view/368 |
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