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Immunogenicity and reactogenicity of an inactivated SARS-CoV-2 vaccine (BBV152) in children aged 2-18 years: interim data from an open-label, non-randomised, age de-escalation phase 2/3 study.
Vadrevu, Krishna Mohan; Reddy, Siddharth; Jogdand, Harsh; Ganneru, Brunda; Mirza, Nizam; Tripathy, Virendra Nath; Singh, Chandramani; Khalatkar, Vasant; Prasanth, Siddaiah; Rai, Sanjay; Ella, Raches; Blackwelder, William; Prasad, Sai; Ella, Krishna.
Afiliação
  • Vadrevu KM; Bharat Biotech, Hyderabad, India. Electronic address: kmohan@bharatbiotech.com.
  • Reddy S; Bharat Biotech, Hyderabad, India.
  • Jogdand H; Bharat Biotech, Hyderabad, India.
  • Ganneru B; Bharat Biotech, Hyderabad, India.
  • Mirza N; Pranaam Hospital, Hyderabad, Telangana, India.
  • Tripathy VN; Prakhar Hospital, Kanpur, India.
  • Singh C; All India Institute of Medical Sciences, Patna, India.
  • Khalatkar V; Meditrina Institute of Medical Sciences, Nagpur, Maharashtra, India.
  • Prasanth S; Cheluvamba Hospital, Mysore, Karnataka, India.
  • Rai S; All India Institute of Medical Sciences, New Delhi, India.
  • Ella R; Independent Consultant, Cambridge, Massachusetts, USA.
  • Blackwelder W; WB Statistical Consulting, Bethesda, Maryland, USA.
  • Prasad S; Bharat Biotech, Hyderabad, India.
  • Ella K; Bharat Biotech, Hyderabad, India.
Lancet Infect Dis ; 22(9): 1303-1312, 2022 09.
Article em En | MEDLINE | ID: mdl-35717995
BACKGROUND: Despite having milder symptoms than adults, children are still susceptible to and can transmit SARS-CoV-2. Vaccination across all age groups is therefore necessary to curtail the pandemic. Among the available COVID-19 vaccine platforms, an inactivated vaccine platform has the advantage of excellent safety profile across all age groups; hence, we conducted an age de-escalation study to assess the safety, reactogenicity, and immunogenicity of an inactivated COVID-19 vaccine, BBV152 (COVAXIN; Bharat Biotech International, Hyderabad, India), in children aged 2-18 years. METHODS: In this phase 2/3 open-label, non-randomised, multicentre study done in six hospitals in India, healthy children (male or female) aged 2-18 years were eligible for inclusion into the study. Children who had positive SARS-CoV-2 nucleic acid and serology tests at baseline, or any history of previous SARS-CoV-2 infection, or with known immunosuppressive condition were excluded. Children were sequentially enrolled into one of three groups (>12 to ≤18 years [group 1], >6 to 12 years [group 2], or ≥2 to 6 years [group 3]) and administered with adult formulation of BBV152 as two 0·5 mL intramuscular doses on days 0 and 28. Co-primary endpoints were solicited adverse events for 7 days post-vaccination and neutralising antibody titres on day 56, 28 days after the second dose. Immunogenicity endpoints were compared with Biodefense and Emerging Infections, Research Resources Repository (BEI) reference serum samples and from adults who received two doses of BBV152 in the same schedule in a previously reported phase 2 study. The trial is registered with the Clinical Trials Registry, India (CTRI/2021/05/033752) and ClinicalTrials.gov (NCT04918797). FINDINGS: From May 27, 2021, to July 10, 2021, we enrolled 526 children sequentially into groups 1 (n=176), 2 (n=175), and 3 (n=175). Vaccination was well tolerated, with no differences in reactogenicity between the three age groups, and no serious adverse events, deaths, or withdrawals due to an adverse event. Local reactions mainly consisted of mild injection site pain in 46 (26%) of 176 participants in group 1, 61 (35%) of 175 in group 2, and 39 (22%) of 175 in group 3 after dose 1; and 39 (22%) of 176 in group 1, 43 of 175 (25%) in group 2, and 14 of 175 (8%) in group 3 after dose 2; there were no cases of severe pain and few reports of other local reactions. After dose 1, the most frequent solicited systemic adverse event was mild-to-moderate fever, reported in eight (5%) of 176 participants in group 1, 17 (10%) of 175 in group 2, and 22 (13%) of 175 in group 3. No case of severe fever was reported, and rates of all fever were all 4% or less after dose 2. Geometric mean titres (GMTs) of microneutralisation antibodies at day 56 in groups 1 (138·8 [95% CI 111·0-173·6]), 2 (137·4 [99·1-167·5]), and 3 (197·6 [176·4-221·4]) were similar to titres in vaccinated adults (160·1 [135·8-188·8]) and with BEI reference serum samples (103·3 [50·3-202·1]). Similar results were obtained using the plaque reduction neutralisation test (PRNT), in which 166 (95%) of 175 participants in group 1, 165 (98%) of 168 in group 2, and 169 (98%) of 172 in group 3 seroconverted at day 56. The GMT ratio of PRNT titres in children and adults was 1·76 (95% CI 1·32-2·33), indicating a superior response in children compared with adults. INTERPRETATION: BBV152 was well tolerated in children aged 2-18 years, and induced higher neutralising antibody responses than those observed in adults, in whom the efficacy (ie, the prevention or decrease in the severity of COVID-19 infection) has been demonstrated. FUNDING: Bharat Biotech International.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Vacinas Virais / COVID-19 Tipo de estudo: Clinical_trials Limite: Adolescent / Child / Child, preschool / Female / Humans / Male Idioma: En Revista: Lancet Infect Dis Assunto da revista: DOENCAS TRANSMISSIVEIS Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Vacinas Virais / COVID-19 Tipo de estudo: Clinical_trials Limite: Adolescent / Child / Child, preschool / Female / Humans / Male Idioma: En Revista: Lancet Infect Dis Assunto da revista: DOENCAS TRANSMISSIVEIS Ano de publicação: 2022 Tipo de documento: Article