Publications by authors named "May Emmeline B Montellano"
Background: Though observational evidence supports indirect effects of SARS-CoV-2 vaccines, randomised experiments are lacking. To address this gap, the double-blinded, prospective follow-up of the household contacts (HHCs) of Philippine participants of the individually-randomised, placebo-controlled trial of the adjuvanted-subunit protein COVID-19 vaccine, SCB-2019, (EudraCT, 2020-004272-17; ClinicalTrials.gov, NCT04672395) was analyzed in a cluster-randomised fashion.
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- SCB-2019, a COVID-19 vaccine candidate, was tested in a study involving 1,278 healthy adolescents aged 12-17 across Belgium, Colombia, and the Philippines to evaluate its immunogenicity and safety compared to placebo.
- The vaccine showed strong immunogenicity, with neutralizing antibody levels in adolescents comparable to those in young adults, particularly for those previously exposed to SARS-CoV-2.
- The SCB-2019 vaccine was well tolerated, with mild to moderate side effects that were similar between adolescents receiving the vaccine and those given a placebo, except for more reported injection site pain in the vaccine group.
Immunogenicity of an adjuvanted SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019) in SARS-CoV-2-naïve and exposed individuals in a phase 2/3, double-blind, randomized study.
Vaccine
March 2023
Background: We evaluated immunogenicity of SCB-2019, a subunit vaccine candidate containing a pre-fusion trimeric form of the SARS-CoV-2 spike (S)-protein adjuvanted with CpG-1018/alum.
Methods: The phase 2/3, double-blind, randomized SPECTRA trial was conducted in five countries in participants aged ≥ 18 years, either SARS-CoV-2-naïve or previously exposed. Participants were randomly assigned to receive two doses of SCB-2019 or placebo administered intramuscularly 21 days apart.
Article Synopsis
- The study evaluated the safety and efficacy of the SCB-2019 COVID-19 vaccine in a large, double-blind, placebo-controlled trial involving over 30,000 adults across five countries.* -
- Participants were randomly assigned to receive either the vaccine or a placebo, and the primary focus was on measuring vaccine effectiveness against COVID-19 and monitoring adverse effects.* -
- Results showed that the vaccine had an overall efficacy of 67.2% against any severity of COVID-19, and 83.7% efficacy against moderate-to-severe cases, indicating its potential effectiveness in preventing the disease.*
Immunogenicity and safety of an adjuvanted inactivated polio vaccine, IPV-Al, compared to standard IPV: A phase 3 observer-blinded, randomised, controlled trial in infants vaccinated at 6, 10, 14 weeks and 9 months of age.
Vaccine
January 2020
Background: A dose-sparing inactivated polio vaccine (IPV-Al), obtained by adsorption of inactivated virus to an aluminium hydroxide adjuvant, can help mitigate global supply and the cost constraints of IPV. The objective of this trial was to demonstrate the non-inferiority of IPV-Al to standard IPV.
Methods: This phase 3, observer-blinded, randomised, controlled trial was conducted at 5 investigational sites in the Philippines.