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Case Reports
. 2019 Spring:1:100005.
doi: 10.1016/j.ympdx.2019.100005.

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

Anthonet Koen  1   2 , Lisa Jose  1   2 , Shabir A Madhi  1   2 , Alan Fix  3 , Stanley Cryz  3 , Michelle J Groome  1   2
Affiliations
Case Reports

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

Anthonet Koen et al. J Pediatr X. 2019 Spring.

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.

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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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References

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