Next Article in Journal
Immunization of Chickens with the Enterobactin Conjugate Vaccine Reduced Campylobacter jejuni Colonization in the Intestine
Next Article in Special Issue
A COVID-19 Vaccine: Big Strides Come with Big Challenges
Previous Article in Journal
BCG Provides Short-Term Protection from Experimental Cerebral Malaria in Mice
Previous Article in Special Issue
Current State and Challenges in Developing Respiratory Syncytial Virus Vaccines
Open AccessReview

Navigating the Quagmire: Comparison and Interpretation of COVID-19 Vaccine Phase 1/2 Clinical Trials

Laboratory of Infectious Diseases, LID Clinical Studies Unit, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA
*
Author to whom correspondence should be addressed.
Vaccines 2020, 8(4), 746; https://doi.org/10.3390/vaccines8040746
Received: 16 November 2020 / Revised: 4 December 2020 / Accepted: 8 December 2020 / Published: 9 December 2020
(This article belongs to the Special Issue Advances in Vaccine Development)
Vaccines against Coronavirus Disease 2019 Originated-19) have been developed with unprecedented rapidity, many utilizing novel strategies. As of November 2020, a series of publications have outlined the results of phase 1/2 studies of nine different vaccines planned to move forward to phase 3 trials. The results are encouraging, demonstrating a paucity of severe or serious adverse events and robust induction of antibody titers. Determination of the vaccine candidates with the highest protective efficacy and best adverse event profiles will be essential in refining public health strategies. However, differences in study design and reporting of data make comparisons of existing phase 1/2 studies difficult. With respect to safety, studies have variable follow-up times and may use different definitions for adverse events. Immunogenicity outcomes are even more inconsistent, with variations in timepoints and critical differences in the types of antibodies studied as well as methodological differences in assays. Furthermore, the correlates of protection in COVID-19 are not known. Harmonization of phase 3 trial designs and use of objective and meaningful clinical outcomes will be crucial in streamlining future global responses to the pandemic. View Full-Text
Keywords: COVID-19; SARS-COV-2; vaccines; clinical trials COVID-19; SARS-COV-2; vaccines; clinical trials
MDPI and ACS Style

Giurgea, L.T.; Memoli, M.J. Navigating the Quagmire: Comparison and Interpretation of COVID-19 Vaccine Phase 1/2 Clinical Trials. Vaccines 2020, 8, 746. https://doi.org/10.3390/vaccines8040746

AMA Style

Giurgea LT, Memoli MJ. Navigating the Quagmire: Comparison and Interpretation of COVID-19 Vaccine Phase 1/2 Clinical Trials. Vaccines. 2020; 8(4):746. https://doi.org/10.3390/vaccines8040746

Chicago/Turabian Style

Giurgea, Luca T.; Memoli, Matthew J. 2020. "Navigating the Quagmire: Comparison and Interpretation of COVID-19 Vaccine Phase 1/2 Clinical Trials" Vaccines 8, no. 4: 746. https://doi.org/10.3390/vaccines8040746

Find Other Styles
Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.

Article Access Map by Country/Region

1
Search more from Scilit
 
Search
Back to TopTop