The immunogenicity, safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immunization schedule.

BACKGROUND: WHO recommended incorporation of Haemophilus influenzae type b (Hib) vaccination into immunization program. Indonesia would adopt Hib as a National Immunization Program in 2013. We aimed at analyzing immunogenicity, safety, and consistency of a new combined DTP-HB-Hib (diphtheria-tetanus-pertussis-Hepatitis B-Haemophilus influenza B) vaccine. METHODS: A prospective, randomized, double blind, multicenter, phase III study of Bio Farma DTP-HB-Hib vaccine conducted in Jakarta and Bandung, August 2012 - January 2013. Subjects were divided into three groups with different batch number. Healthy infants 6-11 weeks of age at enrollment were immunized with 3 doses of DTP-HB-Hib vaccine with interval of 4 weeks, after birth dose of hepatitis B vaccine. Blood samples obtained prior to vaccination and 28 days after the third dose. Safety measures recorded until 28 days after each dose. RESULTS: Of 600 subjects, 575 (96 %) completed study protocol. After 3 doses, 100.0 and 96.0 % had anti-PRP concentration ≥0.15 and ≥1.0 µg/ml. Anti-diphtheria and anti-tetanus concentration ≥0.01 IU/ml detected in 99.7 and 100.0 %; while concentration ≥0.1 IU/ml achieved in 84.0 and 97.4 %. Protective anti-HBs found in 99.3 %. The pertussis vaccine response rate was 84.9 %. None Serious Adverse events (SAEs) considered related to study vaccine or procedure. CONCLUSIONS: The 3-dose of DTP-HB-Hib was immunogenic, well tolerated and suitable for replacement of licensed-equivalent vaccines based on immunologic and safety profiles. TRIAL REGISTRATION: NCT01986335 - October 30(th) 2013.

Case Report: Congenital disseminated tuberculosis neonate born to tuberculosis- COVID-19 mother.

We report a case of a 26-day-old male neonate with high suggestive of congenital disseminated tuberculosis (TB) [tuberculous meningitis (TBM), pulmonary TB, and ocular TB] at term, low birth weight born cesarean section from a confirmed COVID-19 and pulmonary TB mother who hospitalized in the isolation room and never seen her son for three weeks. The baby had a fever for two weeks after birth and a history of seizures. A nasopharyngeal swab for RT-PCR SARS-CoV-2 yielded a negative result. He was initially diagnosed as having a sepsis-like syndrome and then hospitalized. Chest x-ray revealed bilateral infiltrate, cerebrospinal fluid analysis (CSF) showed clear, cell count was 9 with dominant mononuclear cell, and gastric lavages did not yield acid-fast bacilli. X-pert MTB/RIF from gastric lavage specimen detected Mycobacterium tuberculosis rifampicin sensitive. Anti-tuberculosis drugs for TBM were started. Abdominal sonography identified multiple hypoechoic nodules in the liver and spleen. Neuroimaging studies did not identify hydrocephalus, meningeal enhancement, infarct, or tuberculoma. A Video-EEG examination showed electrical seizure after initiation of phenobarbital. Video-EEG evaluation showed no epileptiform discharge. Upon follow-up, he showed slightly delayed motor development, pan-uveitis, retinal detachment, and cataracts. We assumed that ocular TB resulted from a paradoxical reaction following TB treatment. Retinal detachment was improved and lens replacement was done.

The Association of Vitamin D and Neurodevelopmental Status Among 2 Years Old Infants.

The previous studies about association of vitamin D and neurodevelopmental status in the first 1000 days of life showed inconsistent results. This study aimed to investigate correlation between vitamin D deficiency and neurodevelopmental in 2 years old infants. A cross-sectional study was conducted in Sukabumi and Waled, West Java involving 2 years old infants born from the mothers participated in previous cohort. Total 109 infants met the criteria. Vitamin D was measured and neurodevelopmental status was assessed using ASQ-3 in each subject. Statistical analysis using Spearman's Rank correlation and multiple regression model. 50.4% infants had vitamin D deficiency (<50 nmol/L). Neurodevelopmental status showed appropriate for age. No significant association between vitamin D level and neurodevelopmental in 2 years old infants. However, there was an association between some developmental domains and vitamin D level at birth. No correlation between vitamin D and neurodevelopmental in 2 years old infants.