Neutrophil Counts in Healthy South African Infants: Implications for Enrollment and Adverse Event Grading in Clinical Trials in an African Setting

Anthonet Koen, Lisa Jose, Shabir A Madhi, Alan Fix, Stanley Cryz, Michelle J Groome, Anthonet Koen, Lisa Jose, Shabir A Madhi, Alan Fix, Stanley Cryz, Michelle J Groome

Abstract

Absolute neutrophil counts are used to assess eligibility and safety during clinical trials but the toxicity grading scale used can affect enrollment and reporting of adverse events. During a trial investigating a parenteral rotavirus vaccine in South Africa, we excluded otherwise healthy infants without HIV infection from participation owing to neutropenia.

Trial registration: ClinicalTrials.gov: NCT02109484.

Keywords: DAIDS, Division of AIDS; SRC, Safety Review Committee.

© 2019 The Author(s).

Figures

Figure 1
Figure 1
Grading of ANCs in healthy HIV-uninfected South African infants at screening (n = 296) using different toxicity grading scales. CTCAE, Common Terminology Criteria for Adverse Events Version 5.0 Nov 2017; DAIDS, DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events; V1.0 Dec 2004, clarification Aug 2009; V2.0 – November 2014; V2.1 – July 2017; DMID, Division of Microbiology and Infectious Diseases Pediatric Toxicity Tables Nov 2007; FDA, Guidance for Industry, Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials 2007.
Figure 2
Figure 2
Grading of ANCs in healthy HIV-uninfected South African infants at day 7 after the first vaccination (n = 159) using different toxicity grading scales. There were no infants assessed as having life-threatening neutropenia using any of the grading scales. CTCAE, Common Terminology Criteria for Adverse Events Version 5.0 Nov 2017.

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Source: PubMed

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