Title

 

Authors

C. Scollo¹, M. Tuccori^2,3, C. Pisani⁴, G. Giustarini¹, S. Montagnani¹, S. Mantarro¹, C. Cirinei⁴, F. Lena⁵, M. Rubinelli⁴, M. Pardini⁶, L. Bachini⁶, C. Blandizzi^1,2
 
1 Interdepartmental Centre for Research in Clinical Pharmacology and Experimental Therapeutics, University of Pisa
2 Tuscan Regional Centre for Pharmacovigilance
3 Unit of Pharmacology, University Hospital of Pisa
4 Pharmaceutical Unit, Regional Health System, Local Health of Livorno
5 Pharmaceutical Unit, Regional Health System, Local Health of Grosseto
6 Hospital of Livorno, Local Health of Livorno 

 

Abstract

Papilloma virus is the most common sexually-transmissible virus, and it is responsible for nearly 100% of cases of cervix cancer (the second most frequent tumour among women). Bivalent vaccine against human papilloma virus (HPV) is a recombinant vaccine made from highly-purified virus-like particles (VLPs) of the main capsidic L1 protein of the oncogenic types HPV 16 and 18, which are responsible for approximately 70% of cases of cervix cancer in the world. This report describes two cases of alopecia effluvium occurred in two children after administration of anti-HPV bivalent vaccine. Case 1: An11-year old Caucasian female patient developed alopecia effluvium throughout her scalp following the administration of bivalent anti-HPV vaccine. The first dose was delivered in May 2008, the second dose in June 2008, and the third one in November 2008. In July 2008, the child began to display some initial hair loss, which worsened about three weeks later, after receiving the third dose, when the loss became widespread. The child’s mother did not report the concomitant use of any drug. Blood laboratory tests were normal. A diagnosis of vaccine-related alopecia effluvium was made. The patient was treated with local corticosteroids, without benefits. In April 2009, the adverse event receded and the patient recovered progressively. Case 2: An 11-year old Caucasian female patient developed alopecia effluvium throughout her scalp following vaccination with the bivalent anti-HPV vaccine. The first dose was delivered in May 2008, the second dose in June 2008, and the third one in November 2008.About one month after administration of the first dose, the child exhibited a widespread hair loss, which worsened progressively. The use of any concomitant drug was not reported. Laboratory parameters were within the normal range. A dermatologic examination led to the diagnosis of alopecia effluvium of unknown origin. The patient was treated with local corticosteroids, without appreciable benefits. The adverse event recovered spontaneously until resolution 6 months after delivery of the last vaccine dose.The World Health Organization algorithm for the evaluation of a casual relationship between anti-HPV vaccine administration and the occurrence of alopecia effluvium scored as “probable” in both cases. To the best of our knowledge, no cases of alopecia effluvium associated with anti-HPV vaccine administration have been reported previously. However, an autoimmune response leading to the development of alopecia effluvium has been reported for other vaccines, particularly the recombinant hepatitis B vaccine (Geier et al., 2003). Overall, it can be assumed that the bivalent vaccine, administered for HPV prophylaxis, was the most likely cause of alopecia in both the present cases. Nevertheless, based on available data, it is difficult to determine which component of the vaccine can be suggested as responsible for triggering the reported adverse events.Suspension of immunization programs is not recommended, as they provide health benefits that overcome drawbacks resulting from transient hair loss. Whenever alopecia effluvium develops after anti-HPV immunization, physicians should carefully evaluate possible alternative causes (i.e. infectious diseases, other vaccinations, genetic factors). Caregivers should also consider the possibility of ensuring a psychiatric support to the patient; aimed at managing the social and emotional distress which is expected to be associated with hair loss, particularly in children.
 
References
Geier MR et al. Expert Opin Drug Saf 2003;2:113-122